Showing 25 of 519 total entries. View the full timeline of all MAPS MDMA/PTSD projects.

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May 4, 2012

U.S. Veterans Study: Revised Budget Completed, Seventh Subject Treated

The seventh subject out of 24 has now received their first MDMA-assisted psychotherapy session in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans with chronic, treatment-resistant PTSD. We have expanded the study from 16 to 24 subjects, added the possibility of enrolling local firefighters and police officers with work-related PTSD, and revised and updated the budget to accommodate the study expansion.

This study has been ongoing for the past two years, and has an estimated two additional years before completion. We have incorporated into this budget more precise cost estimates based on a review of the actual costs of treating the initial subjects. The total estimated budget for this study is $1.25 million. We have already $600,000, and are seeking to raise the additional $650,000 to complete this study.

The revised budget for this crucial study represents a further professionalization in MAPS’ clinical research procedures. MAPS Director of Clinical Research Amy Emerson created a new budget template for our clinical studies, based on her extensive experience budgeting and monitoring multi-site clinical studies for Novartis. The updated budget distinguishes between start-up costs, site- and procedure-specific patient costs, and internal MAPS staff costs to enable more accurate budget projections for our larger, multi-site Phase 3 studies. The ability to track expenses on a per-patient, per-procedure basis will allow us to understand the implications of protocol changes on clinical research budgets, and by linking our budget to our outcome data analysis to estimate the impact of budgetary changes on our treatment method and clinical results.

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May 4, 2012

U.S. Intern Study: FDA Gives Official Go-Ahead for New Boulder Study

On May 4, 2012, the U.S. Food and Drug Administration notified the MAPS clinical team that our new “intern study” of MDMA-assisted psychotherapy for subjects with PTSD had been cleared for initiation. The study will take place in Boulder, Colorado with Marcela Ot’alora as Principal Investigator. The FDA cleared the study as it was designed, with no changes required prior to initiation. The new study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The use of interns is an effort both to reduce costs and to train the next generation of psychedelic psychotherapists. The study will be initiated once the study physician has received his Schedule I license from the DEA, which we anticipate will take place within the next month.

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May 3, 2012

U.S. Intern Study: DEA Conducts Inspection of MDMA Storage Facility

On May 3, 2012, an official from the Denver office of the Drug Enforcement Administration conducted an inspection of the safe and facility to be used to store the MDMA for our upcoming intern study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The inspection is required to establish that the MDMA storage site is adequately secure and compliant with federal regulations. However, since the safe was at the study physician’s office rather than where the treatments will take place, it will need to be unbolted from the floor and moved to the treatment location. Once the safe has been moved, a new inspection will be required. Once we have met the DEA’s security requirements, the study physician will be granted his Schedule I license and we will proceed with the study initiation and begin screening subjects.

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April 27, 2012

U.S. Relapse Study: First Subject Completes Follow-Up Evaluation after Successful Treatment

On April 27, 2012, the first subject completed their follow-up interview in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in two or three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study. The co-therapists for this study are Dr. Michael Mithoefer and Annie Mithoefer, B.S.N., who also conducted the original proof of principle study. The two-month follow-up evaluation revealed that a single additional open-label MDMA-assisted psychotherapy session was sufficient to reduce this subject’s score on the Clinician-Administered PTSD Scale (CAPS) below the diagnostic cutoff for PTSD. The results suggest that people who relapse after the initial series of treatments as a result of additional life stressors could benefit substantially from a single additional MDMA-assisted psychotherapy session.

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April 23, 2012

DEA Approves License for MDMA Transfer to New Storage Facility

On April 23, 2012, we learned that the U.S. Drug Enforcement Administration had approved the application for a Schedule I MDMA distributor’s license by a contract research firm specializing in synthetic, organic, and medicinal chemistry. This will enable us to transfer the supply of MDMA we use in our U.S. clinical studies to this new facility. The MDMA was originally manufactured in 1985 by Dr. David Nichols at Purdue University, and paid for by MAPS’ predecessor non-profit, Earth Metabolic Design Labs, at a cost of $4/gram. Since Dr. Nichols is retiring from Purdue on June 30, 2012, he will not be able to store the MDMA under his existing Schedule I license after that date. Without an alternative location to store and distribute the MDMA, it would have been destroyed.

Our next step is to identify a facility certified under Good Manufacturing Practices (GMP) that can reprocess the MDMA and certify it as compliant with GMP. Phase 3 trials generally require that investigational drugs be compliant with GMP. The alternative would be to pay to have new MDMA manufactured from scratch. Certifying our existing batch of MDMA as GMP would save MAPS the cost of remanufacturing the drug to be used in our remaining Phase 2 and Phase 3 studies, perhaps as much as $200,000. Obtaining GMP certification for MAPS MDMA would enable us to export it around the world for our international studies, though the facilities storing and distributing the MDMA would need to obtain additional licenses.

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April 16, 2012

U.S. Proof of Principle Study: Revised Long-Term Follow-Up Paper Submitted to Scientific Journal

On April 16, 2012, Dr. Michael Mithoefer, the lead investigator for our recently completed long-term follow-up of subjects who participated in the initial U.S. proof of principle study, submitted a revised version of the paper in response to comments from reviewers. We’re hopeful the paper will soon be accepted for publication. The long-term follow-up, conducted an average of 3½ years after the last MDMA-assisted psychotherapy session, found that the benefits persisted over time, though a few subjects had relapsed due to new life stressors.

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April 8, 2012

U.S. Intern Study: Therapist Teams Complete Training in South Carolina

From April 8-11, 2012, the therapist teams for our MDMA-assisted psychotherapy for PTSD “intern” study completed therapist training in Charleston, South Carolina, with MDMA-assisted psychotherapy researchers and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. The new intern study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The intern study will take place in Boulder, Colorado, and will be our second clinical trial site in the United States.

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March 27, 2012

U.S. Proof of Principle Study: Reviewers Respond to Long-Term Follow-Up Paper

On March 27, 2012, reviewers for a scientific journal responded with their comments on the paper describing the results of our long-term follow-up of subjects who participated in our initial U.S. proof of principle study of MDMA-assisted psychotherapy for PTSD. In their comments and feedback, all four reviewers concluded that it was a strong paper that substantially contributed to the existing scientific research on MDMA-assisted psychotherapy for PTSD. We have incorporated the reviewers’ feedback into the paper, which will be resubmitted for publication in the next few days.

The study, conducted by lead investigator Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., found that the benefits of MDMA-assisted psychotherapy for PTSD persisted for an average of 3½ years after the last treatment. The study found no evidence of harm associated with the administration of MDMA, either immediately following treatment or during the long-term follow-up. These results are even more important than the remarkable results of our initial proof of principle of study as measured at the two-month follow-up, confirming that the benefits of MDMA-assisted psychotherapy persist over time.

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March 27, 2012

U.S. Intern Study: Protocol Passes 30-Day FDA Review Period, Cleared for Initiation

On March 27, the study protocol for our upcoming U.S. intern study of MDMA-assisted psychotherapy for PTSD was cleared for initiation by the FDA after we received no response during the mandated 30-day review period. We contacted the FDA to verify the status of the protocol and learned that they are very busy and we should hear from them in about three weeks. Our research team originally submitted the protocol to the FDA on February 27.  This is not a setback, since the study physician is still waiting on his Schedule I license from the DEA.

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March 20, 2012

U.S. Veterans Study: Seventh Subject Enrolled, Site Visit Completed

On March 20, 2012, the seventh subject out of 24 was enrolled in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. This study, led by Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., will enroll 24 U.S. veterans suffering from chronic, treatment-resistant PTSD occurring as a result of war-related PTSD.

On March 19-23, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., completed a monitoring visit at the site to ensure data accuracy and compliance with Good Clinical Practice (GCP) guidelines.

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March 9, 2012

U.S. Intern Study: IRB Grants Unconditional Approval for Study Protocol

On March 9, the protocol for our planned U.S. intern study of MDMA-assisted psychotherapy for PTSD received approval from the Institutional Review Board, conditional on the pending approval of the study physician’s Schedule I license. The day before, on March 8, the IRB had requested several changes to the subject informed consent documents. MAPS’ clinical team made the changes, resubmitted the documents, and obtained approval in less than 24 hours. The study initiation meeting will be scheduled once the DEA approves the study physician’s license application, which was submitted on March 6. The DEA has no time limit on its response, but we are hopeful that we will be able to begin the study before the summer.

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March 8, 2012

U.S. Intern Study: IRB Grants Conditional Approval, Protocol Submitted to FDA

On March 8, 2012, the protocol for our planned intern study of MDMA-assisted psychotherapy for PTSD received conditional approval from the Institutional Review Board (IRB) pending a few minor modifications to study documents. The protocol was submitted to the FDA on February 27, and is now awaiting review. This study will take place in Boulder, CO, and will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. This approach will help train a new generation of therapists as well as help reduce study costs. The key question is whether outcomes will be similar to when the male/female co-therapist team is composed of two trained therapists.

The protocol was submitted to the IRB on March 1 and reviewed on March 8, the same day conditional approval was granted. This study will take place in Boulder, Colorado, and will be our second U.S. trial site. The study will explore the effectiveness of MDMA-assisted psychotherapy for PTSD using two different doses of MDMA (125 mg followed by a 62.5 mg supplemental dose, and 40 mg followed by a 20 mg supplemental dose). We are evaluating whether a slightly larger low dose (40 mg) than in our previous studies will be a way to create an effective double blind with just two treatment groups. The study will also enable us to make formal comparisons of the effectiveness of the therapy between different therapeutic teams. The Boulder team will participate in our therapist training program in Charleston, SC, from April 8-11, 2012, before beginning the study.

We have already received pledges of $125,000 for this study—about half the total cost—and are seeking the remaining $125,000.

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February 27, 2012

U.S. Intern Study: Protocol Submitted to FDA

On February 27, 2012, the protocol for our planned intern study of MDMA-assisted psychotherapy for PTSD was submitted to the U.S. Food and Drug Administration for review. This study will take place in Boulder, CO, and will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure.

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February 27, 2012

Switzerland: Results Submitted for Publication in Peer-Reviewed Journal

On February 27, 2012, the lead investigator for our now-completed Swiss pilot study of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD submitted a paper describing the results to a peer-reviewed scientific journal. The paper is co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies. The study found clinically significant reductions in scores on the Clinician-Administered PTSD Scale (CAPS)—larger than those associated with Zoloft and Paxil, which are the currently approved medications for PTSD. The small number of subjects in this preliminary pilot study contributed to the results approaching but not reaching statistical significance. The investigators are now awaiting the reviewers’ response to their submission.

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February 25, 2012

U.S. Veterans Study: Sixth Subject Treated, Protocol Amendments Accepted

On February 25, 2012, the sixth subject was treated in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. The fourth protocol amendment (PDF) for this study received “unconditional approval” from the Institutional Review Board on February 22. The FDA has until March 10 to complete its own review. The amendments include expanding the study from 16 to 24 subjects, adding the possibility of enrolling local firefighters and police officers with work-related PTSD, and changing outcome assessment procedures to enable more exact comparisons with other studies. The clinical team is now working on incorporating the amendments into study documents. We have raised the funds for the initial 16 subjects and are now developing the budget for the additional eight subjects.

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February 22, 2012

U.S. Veterans Study: IRB Approves Fourth Protocol Amendment

On February 22, 2012, the fourth protocol amendment for our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD received “unconditional approval” from the Institutional Review Board.

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February 22, 2012

U.S. Veterans Study: IRB Approves Fourth Protocol Amendment

On February 22, 2012, the IRB approved the fourth amendment to our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD.

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February 22, 2012

U.S. Relapse Study: First Subject Treated

On February 22, 2012, the first subject was treated in our relapse study of MDMA-assisted psychotherapy for subjects whose PTSD symptoms returned after participating in our now-completed U.S. flagship study. The initial results are promising. While the long-term follow-up to this study found that the therapeutic benefits of MDMA-assisted psychotherapy were on average sustained over time, two subjects experienced a relapse. This study is an open-label proof-of-principle study, intended to determine whether a single additional MDMA-assisted psychotherapy session and four non-drug psychotherapy sessions can once again eliminate these subjects’ PTSD symptoms. We are seeking $20,000 to complete this study.

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February 22, 2012

Australia: Ethics Committee Rejects Study Protocol, Researchers Prepare Response

On February 22, 2012, an Australian ethics committee rejected the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD. The committee raised issues relating to study design that MAPS and the Australian research team believe can be successfully addressed, and that in some cases represented misunderstandings on the part of the reviewers. MAPS and the Australian psychedelic research group Psychedelic Research in Science and Medicine (PRISM) are now preparing a reply. We are hopeful that a version of the protocol can eventually be approved.

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February 14, 2012

U.S. Veterans Study: Fourth Protocol Amendment Submitted to IRB

On February 14, 2012, the fourth protocol amendment for our ongoing U.S. study of MDMA-assisted psychotherapy for PTSD in veterans of war was submitted to the IRB.

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February 10, 2012

U.S. Veterans Study: Expanded from 16 to 24 Subjects

On February 10, 2012, MAPS’ clinical team submitted a protocol amendment to the FDA with several important changes to our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with chronic, treatment-resistant PTSD. We’ve decided to increase the size of study from 16 to 24 subjects, enhancing the statistical power of the study and enabling us to make more conclusive observations about the therapeutic effectiveness of MDMA-assisted psychotherapy in veterans with service-related trauma. We hope that investigating a treatment for this especially vulnerable group will eventually lead to research funding from the U.S. Department of Defense and/or the Veterans Administration.

The amendments include the added possibility of enrolling firefighters and police officers suffering from PTSD as a result of their service. The addition of these subjects will increase local recruitment and reduce study costs, and will provide further evidence of MDMA-assisted psychotherapy’s effectiveness for an important social group. The study design has also been changed to make the post-second session outcome assessment the primary endpoint for the study. PTSD symptoms will now be assessed after the second experimental MDMA-assisted psychotherapy session rather than the third, as in our upcoming Israeli and Australian studies. This will enable us to conduct a more accurate comparison of results across our international research sites, and to help clarify whether the best treatment model involves two or three experimental MDMA-assisted psychotherapy sessions. The sixth subject in this study was enrolled on January 12.

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February 7, 2012

Australia: Protocol Submitted to Ethics Committee

On February 7, 2012, the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD was submitted to an independent Human Research Ethics Committee (HREC). Subjects in this study will receive two experimental sessions instead of three (as in our U.S. flagship study), enabling us to compare the results with our upcoming Israeli study and helping us to determine whether two or three sessions is more efficient for use in our future Phase 3 studies. Once HREC approves the protocol, it will be submitted to the Australian Therapeutic Goods Administration (TGA) for review.

As in our ongoing study in U.S. veterans, this study will compare the effectiveness of a full dose (125 mg) and a low dose (30 mg) of MDMA in combination with psychotherapy. Unlike our U.S. veterans study, this study will omit the medium dose (75 mg) in order to determine whether we can achieve an effective double-blind with a two-arm (low and medium dose) study.

One of the ways we are expanding our capacity to conduct international clinical trials is by working closely with international affiliates. MAPS is collaborating with the newly formed Australian non-profit organization Psychedelic Research in Science and Medicine (PRISM) to design, fund, obtain approval for, and conduct this first-ever Australian study of the therapeutic application of MDMA.

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February 5, 2012

U.S. Proof of Principle Study: Results of Long-Term Follow-Up Submitted to Scientific Journal

On February 5, 2012, after extensive work, the lead investigator of our first U.S. study of MDMA-assisted psychotherapy for PTSD and co-authors submitted a paper describing the results of our long-term follow-up of subjects who participated in the flagship study. The paper was submitted to a peer-reviewed scientific journal and is now being reviewed for publication. In the original study, 17 of 21 subjects no longer qualified for a diagnosis of PTSD after treatment with MDMA-assisted psychotherapy. The long-term follow-up, conducted an average of 3.5 years after treatment, demonstrates that these benefits were, on average, maintained over time. Additionally, of the subjects who were seeing a therapist prior to the study, 45% were no longer seeing one at the time of the follow-up survey; and 55% of those who were receiving psychiatric medications prior to the study were no longer taking them. Two subjects who participated in the original study experienced a return of symptoms during the long-term follow-up period and will be offered enrollment in our relapse study of MDMA-assisted psychotherapy for PTSD, where they may receive one additional full-dose MDMA session.

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February 1, 2012

Israel: Independent Rater Training Completed

On February 1, 2012, the independent rater for MAPS’ upcoming Israeli study of MDMA-assisted psychotherapy for PTSD completed training on the Clinician-Administered PTSD Scale (CAPS). The CAPS is the primary outcome measure by which our research teams assess the severity of PTSD symptoms before and after treatment with MDMA-assisted psychotherapy. MAPS developed this training program in order to standardize how the CAPS is administered across our diverse study sites. The training includes reviewing of MAPS’ training manual for independent raters, viewing videos of real CAPS interviews produced by the Veterans Administration, and completing assessments of the rater’s ability to reliably administer the CAPS questionnaire. After a final meeting with the clinical team, the site will begin screening and enrolling subjects. Many of the Israeli subjects will be referred by the Israeli Defense Forces.

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January 26, 2012

MDMA-Assisted Treatment for Adult Asperger’s Syndrome: Qualified Research Team Found

On January 26, 2012, the MAPS clinical team finalized negotiations with a qualified research team who responded to our Request for Proposals for an upcoming study of MDMA-assisted treatment for Adult Asperger’s syndrome. MAPS has agreed to contribute $10,000 for protocol development expenses. Asperger’s syndrome is characterized by difficulties in interpreting social cues and nonverbal communication. This study will seek to evaluate how individuals experience certain types of empathy, as well as larger questions of global functioning, before and after MDMA-assisted treatments. The research team will collaborate with the MAPS clinical team to develop a protocol for submission to the FDA, enabling us to begin exploring a new indication within our overall research program into the risks and benefits of MDMA used in a therapeutic setting. We have preliminary budgeted $200,000 for this study, and will refine that estimate as the protocol is developed.

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A Randomized Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans with Chronic Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Michael Mithoefer, M.D., with co-therapist Annie Mithoefer, B.S.N.
Location: Charleston, SC (USA)

This pilot Phase 2 study is examining the safety and efficacy of MDMA-assisted psychotherapy in 24 veterans, firefighter, and police officers with service-related PTSD. We are seeking equal numbers of male and female subjects. This protocol is randomized and triple-blind. All subjects will receive weekly non-drug psychotherapy and three experimental day-long therapy sessions, scheduled three to five weeks apart. We are testing three different doses of MDMA to determine whether this design will result in a successful blind, with subjects, therapists, and the independent rater being uncertain about which subject received which dose. 12 subjects will receive a full 125 mg dose followed by a 62.5 mg supplemental dose; six subjects will receive an active dose of 75 mg followed by a supplemental 37.5 mg dose; and six subjects will receive an active placebo dose of 30 mg followed by a supplemental 15 mg dose.

The findings of this study in veterans with war-related trauma will be compared to the findings from our flagship pilot study of MDMA-assisted psychotherapy for PTSD, which consisted primarily of women survivors of sexual abuse and assault. Previous studies suggest that war-related PTSD may be more prevalent and harder to cure than PTSD caused by other types of trauma, and this study may help establish the relationship between trauma etiology and treatment efficacy.

We are currently seeking research participants for this study. Please visit our participate in research page for more information.

Download the protocol for this study.

We still need to raise approximately $650,000 out of the $1,250,000 needed for this study. Please consider donating today to make sure this study is completed.

View the timeline for this study.

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On December 23, 2009, we submitted our Investigational New Drug (IND) application to the FDA.

• MDMA/PTSD in U.S. War Veterans Protocol submitted to the FDA on December 23, 2009
• Submission Letter to FDA
• IND form 1571
• Principal Investigator form 1572
• Investigator's Brochure
• Original Protocol Part 1, Part 2, Part 3
• Curriculum vitae of Principal Investigator
• Curriculum vitae of Co-Investigator
• Curriculum vitae of Co-Investigator
• Template Informed Consent
• Draft Case Report Forms

On February 1, 2010, our FDA IND application was approved with no changes required.

On April 1, 2010, the FDA accepted the first amendment to our Veterans of War Protocol.

• Cover letter to the FDA
• IRB Approval Letter
• Summary of Changes
• FDA Forms

On August 27, 2010, the Drug Enforcement Administration (DEA) informed Clinical Investigator Michael Mithoefer, M.D., that it had approved his Schedule 1 license.

On August 31, 2010, the second protocol amendment was submitted to the IRB, and approved on September 20.

On September 30, 2010, the second protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.

On August 2, 2011, the third protocol amendment was submitted to the IRB, and approved on August 11.

On August 4, 2011, the third protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.

On February 10, 2012, the fourth protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.

On February 14, 2012, the fourth protocol amendment was submitted to the IRB, and approved on February 22.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)
Principal Investigator: Michael Mithoefer, M.D., with co-therapist Ann Mithoefer, B.S.N.
Location: Charleston, SC (USA)

MAPS’ "proof of principle" Phase 2 pilot study is the first-ever protocol evaluating MDMA’s therapeutic applications in clinical trials conducted under an FDA IND. Like all of MAPS’ psychedelic-assisted psychotherapy studies, the protocol is randomized, double-blind and placebo-controlled. All twenty-one subjects with treatment-resistant PTSD, as a result of sexual abuse, crime, or war, have completed the experimental treatment. The study was completed in September 2008 with remarkably promising results.

On July 19, 2010, the results of this study were published in the Journal of Psychopharmacology. Our paper was the journal's most downloaded article in 2010.

On July 27, 2010, data collection was completed for the long-term follow-up to this study. We collected Clinician-Administered PTSD Scale (CAPS) measurements from 17 of the 20 subjects who received treatment. All 20 subjects filled out a questionnaire developed internally to assess long-term effects. The average length of time between the final experimental treatment session and the follow-up data collection was three and a half years. Preliminary analysis of the results suggests the benefits of the treatment were maintained. The data is currently being analyzed and Dr. Mithoefer and colleagues will write a new paper for submission to a scientific journal in January 2012.

• Dr. Mithoefer's MAPS-sponsored MDMA/PTSD protocol

• The study has cost $1.2 Million; all of which has been raised.

View the timeline for this study.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Relapse Study

An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Psychotherapy Session in People who Relapsed after Participating in a Phase 2 Clinical Trial of MDMA-Assisted Psychotherapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Clinical Investigator: Michael Mithoefer, M.D.
Location: Charleston, SC

This study is limited to up to three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. This relapse study will attempt to determine whether a single additional open-label MDMA-assisted psychotherapy session along with several non-drug psychotherapy sessions can be effective for once again enabling these subjects to be free of a diagnosis of PTSD.

This study has full approval from an Institutional Review Board (IRB), the U.S. Food and Drug Administration (FDA), and the U.S. Drug Enforcement Administration (DEA), and is now being initiated.

• MDMA/PTSD Relapse Study Protocol

This study is expected to cost $31,000, all of which remains to be raised.

View the timeline for this study.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Intern Study

The next phase (Phase 3) of our clinical development plan for MDMA-assisted psychotherapy for PTSD will require many more male/female co-therapist teams than are currently available. Finding a cost-effective and sustainable way to recruit effective therapists is therefore a top priority.

In this pilot study, we will investigate the effectiveness of MDMA-assisted psychotherapy for PTSD when one member of the standard male/female co-therapist team is a healthcare intern (being trained in therapy, social work, or nursing). The other member of the team will be a professional therapist trained in our treatment method. As interns work for free in exchange for fulfilling required training hours under professional supervision, this approach would reduce costs and train the next generation of psychedelic therapists.

Principal Investigator: Marcela Ot'alora, M.A., L.P.C.
Location: Boulder, CO

Subjects will be U.S. veterans with PTSD, mostly from Iraq, Aghanistan, or Vietnam, along with survivors of childhood sexual abuse, assault, rape, and others.

This study has been approved by the Institutional Review Board and cleared by the FDA.

This study is expected to cost $250,000, of which $125,000 remains to be raised.

View the timeline for this study.

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Australian Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

This study will evaluate the safety and effectiveness of MDMA-assisted psychotherapy in 12 subjects with chronic, treatment-resistant PTSD. It will compare the effectiveness of two dosages of MDMA in combination with psychotherapy: a full dose of 125mg (with a supplemental 62.5mg) and a low dose of 30mg (with a supplemental 15mg). Seven subjects will be allocated to the full dose condition, with the remaining five to the low dose condition. Subjects in this study will receive two experimental sessions instead of three, enabling us to compare the results with our other studies and helping us to determine whether two or three sessions is more efficient for use in our Phase 3 studies.

Principal Investigators:Dr. Stuart Saker, MBBS, and Fiona MacKenzie, MPsych(Clinical)
Location: In or near Sydney, Australia

This study is still in the protocol approval stage.

View the timeline for this study.

This study has not yet been budgeted. We anticipate costs in the range of $250,000, of which MAPS has pledged $50,000 if the Australian research team raises $150,000.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Ingrid Pacey, MD and Andrew Feldmar, PhD
Location: Vancouver, BC (Canada)

This study has full approval from an Institutional Review Board (IRB) and from Health Canada. Data will also be submitted to the U.S. FDA. Psychiatrist Ingrid Pacey, M.D., a distinguished Holotropic Breathwork facilitator and psychologist Andrew Feldmar, Ph.D. will be the co-therapists leading the study. We are currently working to obtain an import permit to import the MDMA into Canada from a pharmacologist in Switzerland. The study will begin enrollment after the import permit is obtained and an amended protocol is approved by the IRB.

Canadian MDMA/PTSD pilot study protocol

The study will cost $290,000; $279,000 of which remains to be raised.

View the timeline for this study.

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Israeli Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

This study has the approval of the Israeli Ministry of Health and Ethics Committee, and will be initiated pending clearance by the US FDA.

On January 10, 2011, our clinical team submitted the documents detailing our new protocol for our new Israeli study of MDMA-assisted psychotherapy for PTSD to the Institutional Review Board (IRB) at Beer Yaakov, Israel. On January 19, the ethics committee approved the protocol.

A revised protocol incorporating several changes to the study has been approved by the Israeli ethics committe. After reviewing the revised protocol, the ethics committee forwarded it to the Israeli Ministry of Health, which approved the study on June 1, 2011. The MDMA to be used in the study was previously imported for our earlier Israeli MDMA/PTSD study, so once the FDA has given its final approval we will have the initiation visit and start the study. We anticipate that it will be several months before we are able to begin treating subjects.

We closed our first Israeli MDMA/PTSD study on March 26, 2010, in order to provide more training to the therapeutic teams and to our independent rater, to improve our data collection processes, and to make several improvements to the protocol. There were no Serious Adverse Events (SAEs) and all patients had been treated without evidence of harm. We have reviewed the data from the five subjects who were treated and found self-reports of healing, but quantitative measures did not correspond.

An official at the Israeli Defense Forces has indicated a willingness to refer soldiers with war-related PTSD once the new protocol clears the review process, which will help facilitate recruitment for the study.

New Israeli MDMA/PTSD Pilot Study Protocol (revised February 14, 2011)

View the timeline for this study.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Nasser Shuriquie, M.D. and TBD
Location: Amman, Jordan

This study is currently awaiting approval from the Jordanian Food and Drug Administration (JFDA). It will be conducted under the direction of psychiatrist Nasser Shuriquie, M.D., in Amman, Jordan. We have approval from the IRB at Al-Rashid Hospital. We hope to enroll Iraqi refugees living in Jordan who have PTSD, along with other Jordanians suffering from PTSD.

• The study will cost $136,000; of which we still need $51,000.

Current versions of study documents are below:

• Revised protocol (PDF)
• Revised One Page Protocol Synopsis (PDF)
• Case Report Forms (PDF)
• Curriculum Vitae of Principle Investigator (PDF)

View the timeline for this study.

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Spanish Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (Concluded)

Started in 2000, this study was the world's first clinical trial to evaluate the safety and effectiveness of MDMA-assisted psychotherapy. This dose-response study, in 29 women with chronic, treatment-resistant PTSD caused by rape or childhood sexual abuse, was designed to compare the effectiveness of five dosages of MDMA in combination with psychotherapy: 50 mg, 75 mg, 100 mg, 125 mg, 150 mg. Six of the 29 subjects were treated before pressure from the Madrid Anti-Drug Authority led to the revocation of permission to use the study site. As of May 13, 2002, when the study was shut down for political reasons, we had completed treating four patients in the 50 mg dose group (three patients received 50 mg and one received a placebo), and two people in the 75 mg dose group (one patient received 75 mg and one received a placebo)

Principal Investigator: José Carlos Bouso, PhD
Location: Madrid, Spain

• Study Protocol (PDF)
• Informed Consent Form (PDF)
• Peer-Reviewed Paper on Study Results (PDF)

May 11, 1999: Study protocol approved by the Research Committee of the Hospital Psiquiátrico de Madrid
July 16, 1999: Study protocol approved by the Ethics Committee of the Hospital Universitario La Paz
February 7, 2000: Study approved by the Spanish Agency for Medicines and Health Products
March 2002: Spanish anti-Ecstasy campaign
May 13, 2002: Hospital Psiquiåtrico de Madrid revokes permission to use facilities
May 23, 2002: Study concluded

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Principal Investigator: Peter Oehen, MD, with co-therapist Verena Widmer, RN
Location: Solothurn, Switzerland

All data gathering has been completed and the results are being written up for publication. All 12 subjects with treatment-resistant PTSD have undergone the experimental treatment. The final subject's last visit took place on January 8, 2010. The final analysis was completed in January 2011, after the last measurements for the one-year, long-term follow-up phase of the study were collected from the final subject. The results have been submitted for publication in a peer-reviewed scientific journal.

Our Swiss MDMA/PTSD pilot study had full approval from an Ethics Committee (Swiss IRB equivalent) and SwissMedic (FDA equivalent). The protocol had also been submitted to, and accepted by, the FDA under MAPS’ Investigational New Drug (IND) application for MDMA. The study is a part of MAPS’ clinical plan to develop MDMA into a prescription medicine approved by both the FDA and the European Medicines’ Agency (EMEA).

Swiss MDMA/PTSD pilot study protocol

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Psychological effects of MDMA administration in normal volunteers training to conduct MDMA-assisted psychotherapy research

Principal Investigators: Michael Mithoefer, M.D. and Ann Mithoefer, B.S.N.
Location: Charleston, SC

This Therapist Training/ Phase 1 psychological effects protocol is a placebo-controlled, double-blind, randomized, cross-over study that allows MAPS to administer a single MDMA-assisted psychotherapy session to therapists as part of their training to conduct MAPS' MDMA/PTSD studies, while also conducting a series of evaluations of the psychological effects of MDMA administered to healthy volunteers in a therapeutic context.

This protocol is based in part on a precedent from the 1970s: Dr. Albert Kurland's LSD research team at Spring Grove Hospital in Maryland had FDA permission to administer LSD to help train nurses, attendants and others working with patients in clinical studies, and to mental health professionals (doctors, therapists, counselors, priests, rabbis) to help them better understand patients or congregants who had experienced LSD. Over 100 people received LSD in those training sessions. MAPS submitted letters to FDA from one of the researchers conducting that program, Johns Hopkins researcher William Richards, Ph.D., and from Daniel Helminiak, Ph.D., Ph.D., LPC, a participant in that program. Below you will find a partial list of documents that MAPS has submitted for this study. The list is not comprehensive because the IRB requested that we not include any proprietary documents and information.

On October 3, 2009, MAPS received a letter from the US FDA allowing the study to proceed. On December 21, 2009, we received IRB approval. On August 9, 2010, Dr. Mithoefer received his Schedule 1 license from the DEA to administer MDMA in this study.

Therapist Training Protocol/Phase 1 Psychological Effects: Amendment 2 approved by IRB 12/21/09 (PDF)

This study will cost $85,000, all of which remains to be raised.

Study Timeline

FDA IND application on June 22, 2009

• Submission Letter to FDA (PDF)
• IND form 1571 (PDF)
• IND form 1571 (PDF)
• Investigator's Brochure (PDF)
• Original Protocol (PDF)

FDA Submission of Amendment 1 on September 16, 2009

• Protocol Amendment 1 (PDF)
• MT-1 FDA approval letter (PDF)

IRB submission of Amendment 1 study materials on October 15, 2009

• Submission Letter to IRB (PDF)
• Principal Investigator Form 1572 (PDF)
• Protocol Amendment 1 (PDF)
• Principal Investigator CV (PDF)
• Co-Investigator CV (PDF)
• Investigator Medical License (PDF)
• MP-1 Preliminary Data (PDF)
• Study Rules (PDF)
• Subject Wallet Card (PDF)
• SUDS test (PDF)
• Interpersonal Closeness Test (PDF)
• IRB correspondence (PDF)

The IRB deferred approval of the study on October 26, 2009




We amended the study and re-submitted to the IRB on December 2, 2009

• IRB Submission Letter (PDF)
• MAPS Response to Deferral (PDF)
• Principal Investigator Form 1572 (PDF)
• Helminiak Letter of Support (PDF)
• Johnson Letter of Support (PDF)
• Richards Letter of Support (PDF)
• Protocol Amendment 2 (PDF)
• Case Report Forms (PDF)
• Template Therapy Manual (PDF)
• Johnson et. al. 2008 (PDF)
• IRB questions about study (PDF)
• IRB correspondence on December 14, 2009 (PDF)
• IRB conditional approval on December 16, 2009 (PDF)
• IRB correspondence on December 17, 2009 (PDF)
• IRB correspondence on December 21, 2009 (PDF)

The IRB officially approved the study on December 30, 2009

We submitted Amendment 2 for FDA Approval on December 30, 2009

• FDA Submission Letter (PDF)

This study has been fully approved.

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MDMA-Assisted Psychotherapy in the Treatment of Anxiety Secondary to Advanced Stage Cancer

Sponsor/Principal Investigator: John Halpern, M.D.
Location: McLean Hospital, Harvard Medical School, Belmont, MA (USA)

Dr. Halpern is the Sponsor/Investigator. In his FDA IND application, he cross-referenced MAPS’ IND for MDMA and MAPS will have full access to the data generated from his study. MAPS conducted the design and protocol approval process for this study through a direct gift to McLean Hospital. This study of twelve subjects was also being conducted under US FDA IND and has received IRB approval and DEA registration.

One subject completed the experimental treatment. A second subject participated in the first of two experimental sessions before dropping out due to a decision to resume chemotherapy, which required them to drop out since the study was only for people who were receiving only palliative treatments. No additional subjects were enrolled and the study was closed due to enrollment challenges.

Protocol submitted to FDA on November 26, 2004 (in HTML or PDF format)

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Treatment Manual for MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

Authors: Michael C. Mithoefer, M.D., Lisa Jerome, Ph.D., June M. Ruse, Psy.D., Rick Doblin, Ph.D., Elizabeth Gibson, M.S.

This detailed manual provides therapists conducting MAPS-sponsored MDMA/PTSD studies with standardized methods. MAPS uses this manual to train therapists and evaluate therapist adherence to the described approach.

Draft of Treatment Manual (PDF) describing MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD), revised November 30, 2011.

Draft of Adherence and Competence Protocol for MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD), revised August 19, 2011.

MAPS has also prepared a concept paper that summarizes the rationale, goals, methods, and requirements of our MDMA-assisted psychotherapy research program.

Grant Concept Paper for MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD) Research Program, February 22, 2011.

The project has cost $50,000; $40,000 is still needed.

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Outcome Study of Psychological Defense Mechanisms During MDMA-Assisted Psychotherapy for Treatment of PTSD

Principal Investigators: Pal-Orjan Johansen, Ph.D. (cand) and Teri Krebs

Norwegian University of Science and Technology, Trondheim (Norway)

This study analyzes audio and video recordings of therapy sessions from the ongoing MDMA-assisted psychotherapy studies in the treatment of subjects with PTSD. The objective of this study is to provide empirical evidence on how MDMA influences defense mechanisms in the context of psychotherapy, to understand how MDMA might facilitate the therapeutic process, and to inform the development of a standardized treatment manual for MDMA-assisted psychotherapy.

The study has cost $15,000, with the remainder fully funded.

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September 7, 2010 Here is the most recent version of MAPS’ MDMA Investigator’s Brochure

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Scientific Literature Reviews

MAPS’ comprehensive review of the scientific literature on MDMA Periodic updated reviews of the literature for August/September 2001-January 2003, for 2003-March 2004 (HTML and PDF versions), March 2004-January 2005 (HTML and PDF versions), and a significantly reformatted version covering research up through December 2007 (PDF) Monthly updates of MDMA-related literature MAPS MDMA bibliography with abstracts and PDFs, including a "What’s New" section A review by Alex Gamma, Ph.D. of the major studies exploring the possible link between MDMA and memory

Ricaurte MDMA Research Controversy

Rick Doblin has written a paper discussing how the risks of MDMA neurotoxicity have been exaggerated by government officials and government-funded scientists in a manner that has been used to support prohibitionist policies. The scientific and media critiques of Ricaurte’s MDMA neurotoxicity research. Ricaurte’s July 2003 NIDA Grant Progress Report, obtained 1/26/04 by MAPS through Freedom of Information Act (FOIA) request. Ricaurte explains how he determined he administered methamphetamine instead of MDMA to primates and describes research with genuine MDMA that didn’t cause dopamine reductions. MAPS’ comments on these documents can be found here. Information on grant funding awarded to Dr. George Ricaurte and Dr. Una McCann from 1989 to 2003.

Government Hearings and Conferences

The legal record from DEA’s 1984-1988 MDMA scheduling hearings Testimony by Rick Doblin, Ph.D. and others before US Sentencing Commission hearing on MDMA, 3/19/01 Why MDMA Should Not Have Been Made Illegal by Marsha Rosenbaum and Rick Doblin Meeting agenda and video archives for "MDMA/Ecstasy Research: Advances, Challenges, Future Directions" - NIDA-sponsored conference, July 19-20, 2001.

Media Reports

Merck’s official history of MDMA: Journal article and media report Historical Articles about MDMA 1984-1993 MAPS in the Media Archive: 2000-current

A MAPS History of MDMA

MDMA was synthesized in 1912 and patented in Germany by Merck in 1914 but was not the subject of human research at that time. In the 1950s it was briefly researched by the U.S. Government as part of the CIA’s and the Army’s chemical warfare investigations. It was forgotten until the middle 1970s when it was rediscovered by the psychedelic therapy community and began to be used as an adjunct to psychotherapy by psychiatrists and therapists who were familiar with the field of psychedelic psychotherapy. MAPS published a book, The Secret Chief, about the leader of this therapy community. In the early 1980s, the drug began to be used non-medically, particularly in Texas, under the name Ecstasy. Both the non-medical and therapeutic use of MDMA were made illegal in 1985 despite the Drug Enforcement Administration Administrative Law Judge Francis Young’s recommendation that physicians be permitted to continue to administer it to their patients. Rick Doblin, Alise Agar and Debby Harlow helped coordinate the pro-MDMA contingent in the DEA lawsuit. For an excellent history of the early use of MDMA, see Pursuit of Ecstasy by Beck and Rosenbaum. In 1986, with the goal of developing MDMA’s therapeutic potential through FDA-approved protocols, Rick Doblin founded MAPS as a non-profit research and educational organization with the mission to act as a psychedelic and medical marijuana pharmaceutical company. MAPS immediately opened a Drug Master File for MDMA with data gathered from the standard preclinical animal toxicity studies required by FDA . Subsequently, five different applications for permission to conduct human research with MDMA were submitted to FDA between 1986 to 1988, to the Neuropharmacologic Drug Products Division directed by Dr. Paul Leber. All five applications were rejected. Three protocols for double-blind controlled trials were from researchers at, respectively, Harvard Medical School, UC San Francisco Medical School, and U. of New Mexico Medical School, and were all rejected. Two applications submitted by individual physicians were for single case studies, one for a terminal cancer patient who had been successfully treated for pain with MDMA-assisted psychotherapy prior to the criminalization of MDMA and the other for a unipolar depression patient for whom all available treatments had been attempted without success. Both of these single-patient INDs were also rejected. The FDA based its rationale for rejecting all protocols and single case studies on the hypothetical risk of functional consequences of potential neurotoxicity from MDMA. MDMA research claimed that the rejection of all efforts to conduct FDA-approved MDMA research was based not on rational risk/benefit assessments but on an underlying cultural prejudice against medical research with drugs that were criminalized and on one or more FDA officials’ personal opposition to human research with psychedelics. Since FDA Review Divisions are sometimes described as operating like fiefdoms under the control of their Directors, proponents felt profoundly stymied. Proponents claimed that concerns about MDMA neurotoxicity, which numerous studies had failed to link with functional or behavioral consequence and which in any case had not been clearly demonstrated to occur at all at therapeutic does levels, were reminiscent of scientific research in the 1960s that claimed to prove that LSD damaged chromosomes. These reports were effective in generating public disapproval of LSD and in hindering research but were later determined to have no clinically significant effect. MAPS continued to fund animal toxicity studies at Stanford (1986-1988) and human safety studies at Stanford and Johns Hopkins (1988-1991). In 1992, FDA reviewed a MAPS-supported protocol submitted by Dr. Charles Grob, then at UC Irvine, for a study of the use of MDMA in the treatment of pain, anxiety and depression in cancer patients. FDA’s Drug Abuse Advisory Committee recommended that the cancer patient study be postponed and that a Phase 1 dose-response safety study be conducted first. The protocol was redesigned, with FDA giving final approval for the Phase 1 safety study on November 5, 1992. The safety study was completed in 1995. Data from the safety study revealed no unusual risks and indicated that MDMA could be safely administered within a clinical research context. Dr. Grob submitted the first draft of the protocol for the study of cancer patients in 1997. Negotiations with FDA moved very slowly, due to initial FDA decisions to put MDMA psychotherapy research on a slow track to nowhere. However, FDA opposition eventually lessened as MAPS and Dr. Grob persisted in our efforts to obtain permission for research into the use of MDMA-assisted psychotherapy in cancer patients. A July 24, 1999 teleconference with the FDA concerning MDMA psychotherapy research to treat anxiety, depression and pain in cancer patients went very well, with the FDA indicating a willingness to approve "proof of principle" study. Unfortunately, Dr. Grob’s other work-related responsibilities made it difficult for him to find the time to work on the approval process for this research project. On March 18, 2000, Rick Doblin and Michael Mithoefer met at an ayahuasca conference in San Francisco, sponsored by Ralph Metzner, and begin talking about conducting MDMA psychotherapy research in the US. This marks the beginning of their effort to study subjects with chronic posttraumatic stress disorder. On November 9, 2000, the first subject is treated in Jose Carlos Bouso’s MAPS-sponsored MDMA/PTSD study in Madrid, Spain. On May 13, 2002, the Spain MDMA/PTSD study gets shut down due to political pressure, after six subjects have been enrolled in the study without any persisting adverse effects. Dr. Grob subsequently decided to focus on the use of psilocybin, instead of MDMA, in cancer patients, on the accurate theory that psilocybin research would be less controversial than MDMA research. In June 2003, MAPS starts formally working with Dr. John Halpern, McLean Hospital, Harvard Medical School, on the design of a study administering MDMA-assisted psychotherapy to end-stage cancer patients. Late in 2003, Dr. Grob managed to obtain approval for his psilocybin/cancer patient study.

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PTSD MDMA and PTSD from childhood abuse MDMA and PTSD from a suicide bomber MDMA and PTSD from parent's suicide MDMA and trauma from sexual assault MDMA therapy and PTSD from sexual abuse MDMA and PTSD in a WWII Veteran MDMA and PTSD from violent sexual abuse Meditation and PTSD MDMA combined with meditation for PTSD from childhood trauma MDMA and meditation Cancer and Life-Threatening Illness MDMA and anxiety associated with advanced colon cancer MDMA for a couple dealing with anxiety associated with advanced renal cancer (Part 2/Part 3) MDMA for a father and daughter dealing with anxiety associated with pancreatic cancer MDMA for pain caused by cancer MDMA for coming to terms with life-threatening illness Bipolar Disorder MDMA for trauma and bipolar disorder Couples Therapy MDMA for relationships Chronic Pain Daily low-dose MDMA for chronic pain MDMA for chronic back pain Eating Disorders MDMA for anorexia and bulimia MDMA for eating disorders related to sexual trauma Family Relationships MDMA for father-son relationships MDMA for cancer and father-daughter relationships MDMA for family relationships Parkinson's Disease MDMA for Parkinson's disease. (See Dr. David Nichols'critical commentary) Rheumatoid Arthritis MDMA for rheumatoid arthritis Spiritual, Emotional, and Other Therapeutic Accounts Through the Gateway of the Heart by Raplh Metzner, Ph.D., a classic collection of over 50 personal accounts of MDMA for therapy and personal growth MDMA for psychosis MDMA as a more effective adjunct to therapy than ECT or other drugs MDMA for fear and depression MDMA and ovarian cysts MDMA in neuromuscular therapy MDMA for emotional and physical pain in the elderly MDMA as an adjunct to therapeutic bodywork MDMA and Trichototillomania, Tourette's Syndrome, and Cerebral Palsy

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MDMA Research Around the World Conference on the Clinical Utility of MDMA and MDE (1999) Updates on the Progress of Dr. Grob’s Studies and Protocol Ecstasy (MDMA) mimics the post-orgasmic state by Torsten Passie Structuring Psychotherapy Sessions with MDMA in a Research Context A Review of Clinical Issues in MDMA-Assisted Psychotherapy Ethical caring in psychedelic work The Nature of the MDMA Experience and Its Role in Healing, Psychotherapy, and Spiritual Practice A Family’s Perspective on the Use of MDMA MAPS MDMA Analysis Project A Psychospiritual Context for the Therapeutic Use of Psychedelics Spiritual Uses of MDMA in Traditional Religion Diary of a Subject in the Johns Hopkins MDMA Study MDMA research: more than I bargained for... MDMA Patentability and Orphan Drug Designation The great entactogen - empathogen debate In Memory of Nicholas Saunders Critique of Heffernan Ecstasy/Memory Study by Harry Sumnall (3/28/01) Therapeutic MDMA (Ecstasy) & The Federal Government: A Cloudy Past and a Hopeful Future by Donald David Lewis, a Harvard Law School paper for Prof. Peter Barton Hutt’s Food and Drug Law Class, Winter/Spring 2000. (Word Format)

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DanceSafe and the Ecstasy Harm Reduction Project: MDMA Page Ecstasy.org - Nicholas Saunder’s Site Erowid MDMA Vault Using Psychedelics Wisely May 22, 1986 DEA Ruling on MDMA Scheduling

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