Phase 3 Trials: MDMA-Assisted Psychotherapy for PTSD - News Timeline

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: All Experimental Treatment Sessions Completed in First Trial, Enrollment Continues in Second Trial

As of September 15, 2020, all experimental treatment visits have been completed at the first of two MAPS-sponsored MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) study sites.

MAPS Public Benefit Corporation (MAPS PBC) will lock the database of the first of two FDA-regulated Phase 3 clinical trials in late October.

We are currently seeking research volunteers for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Volunteers will help contribute to scientific knowledge and will help us better understand if MDMA-assisted psychotherapy works for the treatment of PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with federal regulators, including the Drug Enforcement Administration (DEA). To learn more about our clinical trials or apply to be a study participant, visit our website.

We are recruiting participants in the following locations: 

  • Charleston, South Carolina, United States
  • Boulder, Colorado, United States
  • Fort Collins, Colorado, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States Private Practice

Not yet recruiting:

  • San Francisco, California, United States Institution
  • Madison, Wisconsin, United States
  • New York, New York, United States
  • Vancouver, British Columbia, Canada
  • Be’er Ya’akov, Israel
  • Tel Aviv, Israel

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: Currently Enrolling

All fifteen sites have enrolled subjects for our FDA-regulated Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) — and we’re seeking to enroll more volunteers.

Taking place across the United States, Canada, and Israel, study participants will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:

  • Charleston, SC
  • Boulder, CO
  • Fort Collins, CO
  • Los Angeles, CA
  • New Orleans, LA
  • San Francisco, CA (UCSF and private practice)
  • New York, NY (NYU and private practice)
  • Boston, MA
  • University of Wisconsin-Madison
  • Vancouver, British Columbia
  • Montreal, Canada
  • Be’er Ya’akov, Israel
  • Tel HaShomer, Israel (Sheba Medical Center)

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA-assisted psychotherapy as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.

To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: All Sites Enroll a Participant

As of September 17, 2019, fifteen of fifteen sites have enrolled subjects for our FDA-regulated Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).

Taking place across the United States, Canada, and Israel, study participants will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:

  • Charleston, SC
  • Boulder, CO
  • Fort Collins, CO
  • Los Angeles, CA
  • New Orleans, LA
  • San Francisco, CA (UCSF and private practice)
  • New York, NY (NYU and private practice)
  • Boston, MA
  • University of Wisconsin-Madison
  • Vancouver, British Columbia
  • Montreal, Canada
  • Be’er Ya’akov, Israel
  • Tel HaShomer, Israel (Sheba Medical Center)

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA-assisted psychotherapy as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.

To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: 14 Sites Screening Participants

As of August 28, 2019, fourteen of fifteen sites are officially screening for our FDA-regulated Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).

Taking place at 15 locations across the United States, Canada, and Israel, study participants will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:

  • Charleston, SC
  • Boulder, CO
  • Fort Collins, CO
  • Los Angeles, CA
  • New Orleans, LA
  • San Francisco, CA (UCSF and private practice)
  • New York, NY (NYU and private practice)
  • Boston, MA
  • University of Wisconsin-Madison
  • Vancouver, British Columbia
  • Montreal, Canada
  • Be’er Ya’akov, Israel
  • Tel HaShomer, Israel (Sheba Medical Center)

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA-assisted psychotherapy as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.

To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: Now Enrolling

We are currently seeking research volunteers for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Volunteers will help contribute to scientific knowledge and will help us better understand if MDMA-assisted psychotherapy works for PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with all federal regulators, including the Drug Enforcement Administration (DEA). To learn more about our clinical trials or apply to be a study participant, visit our new website.

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: 13 Sites Screening Participants

As of May 15, 2019, thirteen of fifteen sites are officially screening for our FDA-regulated Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Newly screening study sites are Madison, Wisconsin, Vancouver, British Columbia, Montreal, Canada, and Be’er Ya’akov, Israel.

Taking place at 15 locations across the United States, Canada, and Israel, study participants will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:

  • Charleston, SC
  • Boulder, CO
  • Fort Collins, CO
  • Los Angeles, CA
  • New Orleans, LA
  • San Francisco, CA (UCSF and private practice)
  • New York, NY (NYU and private practice)
  • Boston, MA
  • University of Wisconsin-Madison
  • Vancouver, British Columbia
  • Montreal, Canada
  • Be’er Ya’akov, Israel
  • Tel HaShomer, Israel (Sheba Medical Center)

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA-assisted psychotherapy as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.

To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: 10 Sites Screening Participants

As of April 3, 2019, ten of fifteen sites are officially screening for our Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Study participants will be administered MDMA or placebo in conjunction with psychotherapy at research sites in several locations across the United States. To learn more about currently recruiting national and international studies, visit our Participate in Research webpage. Additional Phase 3 sites will be starting in the next several months.

Our FDA-regulated Phase 3 multi-site clinical trials of MDMA-assisted psychotherapy for PTSD are continuing to open sites for screening. Taking place at 15 locations across the United States, Canada, and Israel, study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:

  • Charleston, SC
  • Boulder, CO
  • Fort Collins, CO
  • Los Angeles, CA
  • New Orleans, LA
  • San Francisco, CA (UCSF and private practice)
  • New York, NY (NYU and private practice)
  • Boston, MA
  • University of Wisconsin-Madison
  • Vancouver, British Columbia
  • Montreal, Canada
  • Be’er Ya’akov, Israel
  • Tel HaShomer, Israel (Sheba Medical Center)

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.

To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: 9 Sites Screening Participants

As of March 6, 2019, nine of fifteen sites are officially screening for our Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in several locations across the United States. To learn more about currently recruiting national and international studies, visit our Participate in Research webpage. Additional Phase 3 sites will be starting in the next several months.

Our FDA-regulated Phase 3 multi-site clinical trials of MDMA-assisted psychotherapy for PTSD are continuing to open sites for screening. Taking place at 15 locations across the United States, Canada, and Israel, study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:

  • Charleston, SC
  • Boulder, CO
  • Fort Collins, CO
  • Los Angeles, CA
  • New Orleans, LA
  • San Francisco, CA (UCSF and private practice)
  • New York, NY (NYU and private practice)
  • Boston, MA
  • University of Wisconsin-Madison
  • Vancouver, British Columbia
  • Montreal, Canada
  • Be’er Ya’akov, Israel
  • Tel HaShomer, Israel (Sheba Medical Center)

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.

To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: Study Site Initiation in Tel Hashomer, Israel

On February 5, 2019, a MAPS-sponsored Phase 3 study site for MDMA-assisted psychotherapy for PTSD was initiated in Be’er Ya’akov, Israel. Led by Principal Investigator Jana Yakirevitch, M.D., this study will involve participants with PTSD. Phase 3 trials are beginning in mid-March 2019.

Our FDA-regulated Phase 3 multi-site clinical trials of MDMA-assisted psychotherapy for PTSD are continuing to open sites for screening. Taking place at 15 locations across the United States, Canada, and Israel, study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:

  • Charleston, SC
  • Boulder, CO
  • Fort Collins, CO
  • Los Angeles, CA
  • New Orleans, LA
  • San Francisco, CA (UCSF and private practice)
  • New York, NY (NYU and private practice)
  • Boston, MA
  • University of Wisconsin-Madison
  • Vancouver, British Columbia
  • Montreal, Canada
  • Be’er Ya’akov, Israel
  • Tel HaShomer, Israel (Sheba Medical Center)

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.

To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More

Israel Approves Compassionate Use of MDMA-Assisted Psychotherapy for PTSD

On February 3, 2019, the Israeli Ministry of Health announced the approval of compassionate use for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), which will allow 50 patients to receive the therapy within a treatment protocol. Patients with PTSD will be eligible to receive treatment at four sites throughout Israel, including Rambam Medical Center in Haifa and psychiatric hospitals in Be’er Yaakov, Lev Hasharon, and Be’er Sheva.

“The ministry is taking this seriously and with appropriate caution, an in-depth investigation has been carried out. There is a considerable population in Israel of people suffering from PTSD that is resistant to other treatment,” said Bella Ben-Gershon, the Ministry of Health’s Director of the Department of Treatment of Mental Trauma to Haaretz Newspaper. • Learn More

Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: 8 Sites Screening Participants

This month, our Phase 3 multi-site study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) is continuing to open sites for screening. Eight sites are open for screening at this time. Study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in Charleston, SC, Boulder, CO, Fort Collins, CO, Los Angeles, CA, New Orleans, LA, San Francisco, CA and New York City, NY. To learn more about currently recruiting national and international studies, visit our participate in research webpage

Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD are taking place at 15 locations across the United States, Canada, and Israel. Eight study sites are currently recruiting participants.

Our Phase 3 researchers have completed a total of eleven study site initiation visits for Phase 3 within the United States, and we are scheduling three study site initiation visits for additional study sites in the United States, Canada, and Israel in the coming months.

The Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. • Learn More

Medical-Grade MDMA Arrives at Multiple Phase 3 Clinical Trial Sites

This month, MAPS study sites in New Orleans, Louisiana, Charleston, South Carolina, Fort Collins, and Boulder, Colorado received a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices (GMP) in a certified laboratory, to be administered in conjunction with psychotherapy to study participants.

Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD are taking place at 15 locations across the United States, Canada, and Israel.

Our Phase 3 researchers have completed a total of eight study site initiation visits for Phase 3 within the United States, and we are scheduling seven study site initiation visits for remaining study sites in the United States, Canada, and Israel in early 2019.

Do you have PTSD? You may qualify for a study of an investigational drug (MDMA) used in combination with psychotherapy. • Learn More

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. • Learn More

Phase 3 Trials: Recruitment Opens for New Trials of MDMA-Assisted Psychotherapy for PTSD

Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD have officially launched. These trials are taking place at 14 locations across the United States, Canada, and Israel.

On November 19, 2018, MAPS received a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices (GMP) in a certified laboratory, which will be administered in conjunction with psychotherapy to study participants in our upcoming trials.

Our Phase 3 researchers have completed a total of eight study site initiation visits for Phase 3 within the United States, and we are scheduling seven study site initiation visits for remaining study sites in the United States, Canada, and Israel in early to mid-2019.

Do you have PTSD? You may qualify for a study of an investigational drug (MDMA) used in combination with psychotherapy. • Learn More

Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. • Learn more…

21 Participants Enrolled in Open-Label Lead-In Study of MDMA-Assisted Psychotherapy for PTSD

MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at 8 United States locations:

  • New Orleans, Louisiana
  • Fort Collins, Colorado
  • Boulder, Colorado
  • Private Practice, San Francisco, California
  • University of California, San Francisco, California
  • Los Angeles, California
  • Charleston, South Carolina
  • New York, New York

Twenty-one participants have completed treatment in our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. Seven study sites are now enrolling and 7 sites are fully enrolled. The study is expected to be completed in early 2019. The purpose of this study is to provide the final training and provide supervision for our co-therapy teams.

Phase 3 clinical trials starting Fall 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. Learn more…

Phase 3 Trials: Study Initiation Visits for 8 Sites Completed

MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at 8 United States locations:

  • New Orleans, Louisiana
  • Fort Collins, Colorado
  • Boulder, Colorado
  • Private Practice, San Francisco, California
  • University of California, San Francisco, California
  • Los Angeles, California
  • Charleston, South Carolina
  • New York, New York

Fifteen participants have completed treatment in our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. Seven study sites are now enrolling and 7 sites are fully enrolled. The study is expected to be completed in early 2019. The purpose of this study is to provide the final training and provide supervision for our co-therapy teams.

Clinical trials starting Fall 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. Learn more…

Phase 3 Trials: Study Initiation Visits for 5 Sites Completed

MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at five United States locations:

  • New Orleans, Louisiana
  • Fort Collins, Colorado
  • Boulder, Colorado
  • Private Practice, San Francisco, California
  • University of California, San Francisco, California
  • Los Angeles, California

These Phase 3 trials are taking place at up to 16 sites in the U.S., Canada, and Israel.

Clinical trials are starting in September 2018, and will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. Learn more…

Phase 3 Trials: Participant Enrollment Begins This Summer

As summer comes to a close, we will begin the process of screening applications and enrolling participants for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), taking place at up to 16 sites in the U.S., Canada, and Israel.

These Phase 3 trials are starting in September 2018, and will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay. Learn more…

Phase 3 Trials: MAPS Meets with European Medicines Agency (EMA)

On June 12, 2018, MAPS had a successful meeting in London, United Kingdom, with the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA). The discussion focused on scientific advice for the clinical development of MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder (PTSD). Data gathered in European trials would provide support for a planned Marketing Authorization Application for EMA.

Key notes:

  • MAPS' efforts to work with the EMA are moving forward well
  • MAPS will likely to be able to move to Phase 3 MDMA research in Europe
  • We will need increase the number of subjects and countries for Phase 3 research in the EU
  • EMA research is more complex that FDA research
  • MAPS will host a training for European therapists from September 27 - October 3, 2018.
  • EMA Phase 3 is scheduled to start late in the summer of 2019

The U.S. FDA-regulated Phase 3 trials starting in August 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at up to 16 sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay. Learn more…

Study Initiation Visit Conducted for MDMA-Assisted Psychotherapy for PTSD Study Site in Fort Collins, Colorado

On May 24, 2018, Clinical Research Associate, Gabrielle Fortier, M.P.H., of the MAPS Public Benefit Corporation (MPBC), conducted a Study Initiation Visit for a Phase 3 study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at the planned Phase 3 site in Fort Collins, Colorado. A Study Initiation Visit for the Boulder, Colorado study site will be scheduled for June 13, 2018.

The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.

Study Initiation Visits Begin for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On Thursday, April 26, 2018, Rebecca Matthews, Clinical Operations Manager of the MAPS Public Benefit Corporation (MPBC), traveled to New Orleans, Louisiana, to conduct the first Study Initiation Visit for the Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). After the New Orleans Phase 3 site was initiated, researchers completed Study Initiation Visits at planned Phase 3 sites in Fort Collins and Boulder, Colorado.

MPBC clinical research staff have completed 13 of 14 Study Initiation Visits for our open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. The purpose of this study is to provide the final training for our co-therapy teams.

The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.

On July 28, 2017, MAPS and the FDA reached agreement on the design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.

On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.

MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $26.7 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $26.2 million in hand or in multi-year pledges, there's still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will likely require additional funds. MAPS began negotiations with EMA in January 2018, and MAPS staff will likely travel to London, United Kingdom, to meet with EMA in June 2018. Learn more...

There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help us heal trauma: maps.org/donate

MAPS Receives Shipment of GMP MDMA for Phase 3 Trials

On March 13, 2018, a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices in a certified laboratory, arrived in the United States for use in MAPS-sponsored Phase 3 trials of treating posttraumatic stress disorder (PTSD) with MDMA-assisted psychotherapy.

MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 13 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for PTSD at planned Phase 3 sites across the United States and Canada. The purpose of this study is to provide the final training for our co-therapy teams.

These Study Initiation Visits provide training on study procedures to study sites where new co-therapy teams will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS' therapy training team.

The study site in Fort Collins has conducted experimental treatment sessions with three participants, and the New Orleans study site has completed their second experimental treatment session. Study sites in Charleston, Los Angeles, San Francisco (two locations), Connecticut, New York (private practice), and Vancouver are screening participants.

The study site in Boulder, Colorado, received the necessary study drug on March 20. The study site in New York (private practice) will receive the study drug on March 28.

The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials builds on the promising results of MAPS' completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD. MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting with an overnight stay.

On July 28, 2017, MAPS and the FDA reached agreement on the design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.

On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.

MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $26.7 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $26.2 million in hand or in multi-year pledges, there's still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will require additional funds so MAPS is starting to try to raise $5 million for our EMA research. MAPS began negotiations with EMA on March 1, and will travel to London, United Kingdom, to meet with EMA in Summer 2018. Learn more...

Participant Enrollment and Treatment Begins in Open-Label Lead-In Study of MDMA-Assisted Psychotherapy for PTSD at Phase 3 Sites

MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 12 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. The purpose of this study is to provide the final training for our co-therapy teams. These Study Initiation Visits provide training on study procedures to study sites where new co-therapy teams will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS' therapy training team.

The study site in Fort Collins has conducted experimental treatment sessions with two participants, and the New Orleans study site has completed their first experimental treatment session, and other sites will start enrolling participants soon.

The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

Enrollment for Phase 3 trials is expected to start in the summer of 2018 in the following locations:

  • Los Angeles, CA | private practice
  • San Francisco, CA | research institution
  • San Francisco, CA | private practice
  • Boulder, CO | private practice
  • Fort Collins, CO | private practice
  • New Orleans, LA | private practice
  • New York, NY | research institution
  • New York, NY | private practice
  • Charleston, SC | private practice
  • Madison, WI | research institution
  • Boston, MA | research institution
  • Montreal, Canada | private practice
  • Vancouver, Canada | research institution
  • Tel Aviv, Israel | research institutions

The trials build on the promising results of MAPS' completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.

On July 28, 2017, MAPS and the FDA reached agreement on the design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.

On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.

MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $26 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $18 million in hand or in multi-year pledges, there's still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will likely require additional funds, with MAPS beginning negotiations with EMA in February 2018. EMA agreement is anticipated by the end of Summer 2018. Learn more...

There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help us heal trauma: maps.org/donate

Participant Enrollment and Treatment Continues in Open-Label Lead-In Study of MDMA-Assisted Psychotherapy for PTSD at Phase 3 Sites

MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 13 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. The purpose of this study is to provide the final training for our co-therapy teams.

On February 13, 2018, Senior Clinical Research Associate Charlotte Harrison of MAPS Public Benefit Corporation (MPBC) traveled to Colorado for a Site Initiation Visit of the open-label lead-in study site in Boulder where we will conduct MDMA-assisted psychotherapy for PTSD. These Study Initiation Visits provide training on study procedures to study sites where new co-therapy teams will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS' therapy training team.

Charlotte also led an Interim Monitoring Visit on February 12 and 14 at the open-label lead-in study site in Fort Collins, Colorado.

The study site in Fort Collins has conducted experimental treatment sessions with two participants, and the New Orleans study site has completed their first experimental treatment session, and other sites will start enrolling participants soon.

The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

A total of 7 study sites have been granted a Schedule I license by the U.S. Drug Enforcement Administration (DEA):

  • Los Angeles, CA
  • San Francisco, CA
  • Fort Collins, CO
  • New Orleans, LA
  • New York, NY
  • Charleston, SC

The Phase 3 trials build on the promising results of MAPS' completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD. Once approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting.

Within the next month, sites in Charleston, South Carolina and in New York City will begin screening and recruiting participants for enrollment.

A total of 6 study sites have received the necessary study drug:

  • San Francisco, CA (received Jan.9)
  • Los Angeles, CA (received Jan. 25)
  • Fort Collins, CO(received Dec. 19)
  • New Orleans, LA (received Dec. 20)
  • Charleston, SC (received Feb. 21)

On July 28, 2017, MAPS and the FDA reached agreement on the design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.

On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.

MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $26 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $20+ million in hand or in multi-year pledges, there's still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will likely require additional funds, with MAPS beginning negotiations with EMA on March 1. EMA agreement is anticipated by the end of Summer 2018. Learn more...

There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help us heal trauma: maps.org/donate

MDMA Phase 3 Trials: FDA and DEA Host Breakthrough Therapy Meetings

On Monday, December 18, MAPS’ clinical team met with our pro-bono pharmaceutical lawyer, Peter Barton Hutt of Covington & Burling. On Tuesday, December 19, MAPS’ clinical team leaders, Executive Director, and U.S. Drug Enforcement Administration (DEA) consultant met with the DEA at their headquarters in Arlington, Virginia. The discussion focused on streamlining plans for Schedule I licenses for researchers and potential Expanded Access therapists.

On Wednesday, December 20, 17 staff from the U.S. Food and Drug Administration (FDA) met with MAPS researchers and staff from MAPS Public Benefit Corporation (MPBC) at FDA's White Oak Campus in Silver Spring, Maryland. This was our first meeting under the Breakthrough Therapy Designation program to discuss various issues related to our Phase 3 clinical trials and potential prescription approval of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).

MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 11 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. These Study Initiation Visits provide training on study procedures to clinical trial sites that will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3.

Starting at some Phase 3 sites now and continuing until June 2018, we will conduct the open-label lead-in training study. We will enroll 1-4 participants per site. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS' therapy training team.

The Phase 3 trials starting next year will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

Enrollment is expected to start in the summer of 2018 in the following locations:

  • Los Angeles, CA | private practice
  • San Francisco, CA | research institution
  • San Francisco, CA | private practice
  • Boulder, CO | private practice
  • Fort Collins, CO | private practice
  • New Orleans, LA | private practice
  • New York, NY | research institution
  • New York, NY | private practice
  • Charleston, SC | private practice
  • Madison, WI | research institution
  • Boston, MA | research institution
  • Montreal, Canada | private practice
  • Vancouver, Canada | research institution
  • Tel Aviv, Israel | research institutions

The trials build on the promising results of MAPS' completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.

On July 28, 2017, MAPS and the FDA reached agreement on the Special Protocol Assessment for Phase 3 clinical trials. This agreement confirms that that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.

On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.

MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $26 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021, with approval from the European Medicines Agency (EMA) possibly requiring additional funds. With $15.5 million in hand or in multi-year pledges, there's still a funding gap we need to close. Learn more...

Study Initiation Visits Continue for Phase 3 Lead-In Trials of MDMA-Assisted Psychotherapy for PTSD

MAPS Public Benefit Corporation (MPBC) clinical research staff have now completed 11 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. These Study Initiation Visits provide training on study procedures to clinical trial sites that will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3.

Starting at some Phase 3 sites now and continuing until June 2018, we will conduct the open-label lead-in training study. We will enroll 1-4 participants per site. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS’ therapy training team.

The Phase 3 trials starting next year will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

Enrollment is expected to start in the summer of 2018 in the following locations:

  • Los Angeles, CA | private practice
  • San Francisco, CA | research institution
  • San Francisco, CA | private practice
  • Boulder, CO | private practice
  • Fort Collins, CO | private practice
  • New Orleans, LA | private practice
  • New York, NY | research institution
  • New York, NY | private practice
  • Charleston, SC | private practice
  • Madison, WI | research institution
  • Boston, MA | research institution
  • Montreal, Canada | private practice
  • Vancouver, Canada | research institution
  • Tel Aviv, Israel | research institutions

The trials build on the promising results of MAPS' completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.

On July 28, 2017, MAPS and the FDA reached agreement on the Special Protocol Assessment for Phase 3 clinical trials. This agreement confirms that that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.

On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.

MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $26 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021, with approval from the European Medicines Agency (EMA) possibly requiring additional funds. With $15.5 million in hand or in multi-year pledges, there's still a funding gap we need to close. Learn more...

There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help us heal trauma: maps.org/donate

Health Canada Clears Training Study of MDMA-Assisted Psychotherapy for PTSD at Canadian Phase 3 Sites

On October 4, 2017, Health Canada, the Canadian federal institution that regulates drug and health products, sent a No Objection Letter on the protocol and design for the MAPS-sponsored Phase 2 Training Study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), conducted at planned Phase 3 study sites in Vancouver and Montreal.

MAPS Public Benefit Corporation (MPBC) clinical research staff have now completed 10 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. These Study Initiation Visits provide training on study procedures to clinical trial sites that will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3.

We will conduct the open-label lead-in training study at Phase 3 sites starting this fall, which will enroll 1-4 participants per site over the next 6-8 months. Each co-therapy team will work with a single participant at their respective study site.

The Phase 3 trials starting early next year will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy under direct observation over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

Enrollment is expected to start in the spring of 2018 in the following locations:

  • Los Angeles, CA | private practice
  • San Francisco, CA | research institution
  • San Francisco, CA | private practice
  • Boulder, CO | private practice
  • Fort Collins, CO | private practice
  • New Orleans, LA | private practice
  • New York, NY | research institution
  • New York, NY | private practice
  • Charleston, SC | private practice
  • Madison, WI | research institution
  • Boston, MA | research institution
  • Montreal, Canada | private practice
  • Vancouver, Canada | research institution
  • Israel | research institution

The trials build on the promising results of MAPS' completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.

MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS' goal of raising $25 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021, with approval from the European Medicines Agency (EMA) possibly requiring additional funds. With $15.5 million in hand or in multi-year pledges, there's still a funding gap we need to close. Learn more...

Study Initiation Visits Begin for Phase 3 Lead-In Trials of MDMA-Assisted Psychotherapy for PTSD

Throughout September 2017, MAPS and MAPS Public Benefit Corporation (MPBC) clinical staff completed 9 of 14 study initiation visits for sites selected to conduct Phase 3 lead-in trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) across the United States and Canada. These study initiation visits serve to train clinical trial sites in study procedures.

We will conduct an open-label lead-in training study at Phase 3 sites starting this fall, which will enroll 1-4 participants per site over the next 6-8 months. Each co-therapist team will work with a single participant at their respective study site.

The Phase 3 trials starting early next year will assess the efficacy and safety of MDMA-assisted psychotherapy in participants with PTSD, aged 18 and older, at sites in the U.S. and Canada. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters. Learn more...

FDA Grants MAPS Breakthrough Therapy Designation for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. Breakthrough Therapy Designation also means that the FDA will work closely with MAPS to provide guidance on the development of MDMA for post-traumatic stress disorder to design and conduct the development program as efficiently as possible.

On July 28, 2017, MAPS and the FDA reached agreement on the Special Protocol Assessment for Phase 3 clinical trials. This agreement confirms that that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA. Learn more...

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MAPS Submits Breakthrough Therapy Designation Application to FDA for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On June 22, 2017, MAPS submitted to the U.S. Food and Drug Administration (FDA) an application for Breakthrough Therapy designation for our upcoming Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). If approved, Breakthrough Therapy designation could expedite the development and review of MDMA-assisted psychotherapy for PTSD.

On June 27, the U.S. Food and Drug Administration (FDA) provided clearance for the initiation of our upcoming open-label Phase 2 study of MDMA-assisted psychotherapy for PTSD, taking place at all upcoming Phase 3 study sites in the United States. Participants with PTSD will receive MDMA-assisted psychotherapy from supervised co-therapy teams who will receive supervision by our our adherence raters and clinical training team in order to provide necessary experience for therapists transitioning to Phase 3 trials. Site initiation visits will begin in August and continue through September.

Our revised Phase 3 protocol evaluating MDMA-assisted psychotherapy for PTSD was granted unconditional approval by the Copernicus Group Institutional Review Board (IRB) on June 27. We expect to receive a response from the FDA regarding the Special Protocol Assessment process and our revised Phase 3 protocol by July 27.

Donations are currently being sought to reach MAPS' goal of raising $25 million, with $10 million already raised, to successfully execute the Phase 3 studies required to gain approval from FDA for MDMA-assisted psychotherapy by 2021.

Learn more...

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FDA Comments on Special Protocol Assessment (SPA) for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On June 13, as part of FDA’s Special Protocol Assessment process, MAPS submitted to FDA a revised Phase 3 protocol evaluating MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The protocol was revised based on discussions between MAPS and FDA during our May 11, 2017 Type A meeting and on FDA’s official meeting minutes we received on May 30, 2017. Based on the agreements reached during the May 11 Type A meeting we’re hopeful this will be our final revision.

Donations are currently being sought to reach MAPS' goal of raising $25 million, with $10 million already raised, to successfully execute the Phase 3 studies required to gain approval from FDA for MDMA-assisted psychotherapy by 2021. Learn more...

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FDA and MAPS Agree on Protocol for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On May 11, 2017 MAPS and MPBC staff held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the upcoming Phase 3 clinical trial of MDMA-assisted psychotherapy for PTSD. At the meeting, all of the FDA’s concerns were addressed and no outstanding questions remain.

There are no road blocks to moving forward with Phase 3 as the FDA gave favorable feedback to MAPS and MPBC’s responses to FDA questions. With this collaborative meeting, we will be able to move forward with re-submitting the protocol and our Statistical Analysis Plan, the next step in the Special Protocol Assessment process. MAPS' submission will go to FDA after it sends us official minutes of the May 11 teleconference by mid-June.

The review period after the next submission will be a month and a half. MAPS and MPBC staff are optimistic and excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted Psychotherapy. Donations are currently being sought to reach MAPS’ goal of raising $25 million, with $10 million already raised, to successfully execute the Phase 3 studies required to gain approval from FDA for MDMA-assisted psychotherapy by 2021. Learn more...



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FDA Responds About Special Protocol Assessment (SPA) for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On March 9, 2017, MAPS received a response from the U.S. Food and Drug Administration (FDA) as part of our Special Protocol Assessment (SPA) for our Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The FDA provided comments based on a rigorous and lengthy review of the Phase 3 trial design to ensure the Phase 3 data will be accepted at the time of the New Drug Application (NDA). The first round of SPA comments has been received, and key design elements of the Phase 3 protocol have been finalized. We have been granted a Type A Meeting with the FDA on May 11 to discuss the comments.We are currently preparing for a Type A Meeting with FDA to discuss the comments. Learn more...

FDA Receives Protocol for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On January 23, 2017, the U.S. Food and Drug Administration (FDA) confirmed their receipt of MAPS’ protocol for Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The FDA allots 45 days to complete their Special Protocol Assessment (SPA) process, which is a rigorous review of the Phase 3 trial design that could result in the FDA committing to approve MDMA-assisted psychotherapy for PTSD should the protocol as designed provide sufficient evidence proving safety and efficacy.

We expect to initiate our first Phase 3 clinical trial in the second half of 2017, which will last 2-3 years and enroll at least 200 participants. As a non-profit with no government funding yet for MDMA research, we anticipate it will cost between $25-$33 million over the next five years to complete two Phase 3 trials, seeking approval from both the FDA and the European Medicines Agency (EMA). Over $10 million has already been raised or pledged. Phase 3 trials are the final stage of research needed before the FDA and EMA will decide whether to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD. There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Learn more...

Phase 3: MAPS Prepares to Request Breakthrough Therapy Designation and Special Protocol Assessment

On December 13, 2016, the U.S. Food and Drug Administration (FDA) participated in a teleconference with MAPS to discuss whether we should apply for Breakthrough Therapy Designation for MDMA-assisted psychotherapy as a treatment for posttraumatic stress disorder (PTSD). "It was a very helpful meeting, and we were encouraged to proceed with applying for Breakthrough Therapy Designation," explains MAPS-sponsored researcher Michael Mithoefer, M.D.

If approved, Breakthrough Therapy Designation could expedite the development and review of MDMA-assisted psychotherapy for PTSD. According to the FDA, a breakthrough therapy is intended “to treat a serious or life threatening disease condition,” and “may demonstrate substantial improvement over existing therapies.”

In the next few weeks, we will also submit to the FDA our Phase 3 trial protocol for the Special Protocol Assessment (SPA) process. The SPA process is a rigorous review of the Phase 3 trial design that could result in FDA committing to approve MDMA-assisted psychotherapy for PTSD should the protocol as designed prove safety and efficacy.

As a non-profit with no government funding for MDMA research, we anticipate it will cost between $25-$30 million to complete these Phase 3 trials over the next five years, with over $10 million already raised or pledged. Phase 3 trials are the final stage of research needed before the FDA will decide whether to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD. There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Learn more...

FDA Agrees to Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD

On November 29, 2016, the U.S. Food and Drug Administration (FDA) hosted staff and researchers at MAPS and the MAPS Public Benefit Corporation (MPBC) for a formal End of Phase 2 Meeting to discuss clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). During the 90-minute meeting at the FDA’s White Oak Campus in Silver Spring, Maryland, the FDA stated they are now ready for MAPS to move forward with Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. The formal approval of the Phase 3 trial protocol is expected by mid-April 2017.

On November 30, 2016, The New York Times published a feature article announcing the outcome of our End of Phase 2 meeting with the FDA. Trial participants Ed Thompson and CJ Hardin spoke with the NYTimes about how MDMA-assisted psychotherapy helped them overcome treatment-resistant PTSD. “It changed my life,” explains Ed. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.” CJ speaks about the results from his treatment, stating, “The MDMA sessions showed me a light I could move toward. Now I’m out of the darkness and the world is all around me.”

We expect to initiate our first Phase 3 clinical trial in June 2017, which will last 2-3 years and enroll at least 230 participants. We are working with the FDA’s guidance on determining the final form of the Phase 3 trials, including selection of appropriate control group and sample size.

We need to raise approximately $25 million to complete these Phase 3 trial and all associated toxicity and pharmacology studiesover the next 5 years.Phase 3 trials are the final stage of research needed before the FDA will decide whether to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD. There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Learn more...

Phase 3 Trials: FDA Receives End of Phase 2 Documents

On October 12, 2016, the U.S. Food and Drug Administration (FDA) confirmed their receipt of MAPS’ materials in support of our End of Phase 2 meeting with the FDA, scheduled for November 29, 2016. The submission included a 90-page summary of initial indications of safety and efficacy based on our Phase 2 results, plus what is now known about the toxicology, pharmacology, and abuse liability of MDMA from over 5000 peer-reviewed scientific papers published on MDMA or Ecstasy. We also had multiple attachments consisting of our Chemistry, Manufacturing, and Control (CMC) proposal for MDMA production under current Good Manufacturing Practice (cGMP) standards for Phase 3 and post-approval formulation, toxicological study proposals, key elements of MDMA-assisted psychotherapy, and key references. The goal of our End of Phase 2 Meeting will be to come to an agreement on the design of our upcoming Phase 3 trials, the final stage of research required to gather evidence proving safety and efficacy sufficient for FDA to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD. Learn more…