On February 26, 2019, MAPS Public Benefit Corporation (MAPS PBC) staff and researchers gathered for a publication meeting and data unblinding for the MAPS-sponsored clinical trial of smoked marijuana (cannabis) as a treatment for PTSD symptoms in veterans. All 76 participants have completed treatment, and the data from the study are now being analyzed and prepared for publication later this year in a peer-reviewed biomedical journal. • Learn More

On February 8, 2019, MAPS-sponsored researchers officially completed the first-ever clinical trial of smoked marijuana (cannabis) as a treatment for PTSD symptoms, with all 76 veterans enrolled and treated. The data from the study are now being analyzed and prepared for publication later this year in a peer-reviewed biomedical journal.

“We are thrilled to finally be at the finish line of this nearly 10-year saga trying to get this crucial clinical trial completed,” said Site Principal Investigator Sue Sisley, M.D. “We are immensely grateful to all of the study’s supporters, especially the veteran service organizations who helped us with patient recruitment.” • Read the Press Release

As of November 1, 2018, all participants completed treatment in the first-ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial is evaluating the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. • Learn more...

As of October 8, 2018, the 76th and final participant enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans, completing enrollment. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial is evaluating the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Learn more...

As of September 18, 2018, 75 of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans, nearly completing enrollment. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Our recruitment website can be visitedhere. Learn more...

As of Thursday, August 9, 2018, 71 of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Gabrielle Fortier, M.P.H., Clinical Research Associate of the MAPS Public Benefit Corporation (MPBC), will monitor the site September 4 - 7, 2018. Our recruitment website can be visited here. Learn more...

As of Wednesday, July 18, 2018, 69 of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Gabrielle Fortier, M.P.H., Clinical Research Associate of the MAPS Public Benefit Corporation (MPBC), monitored the site from July 16 - 20, 2018. Our recruitment website can be visited here. Learn more...

As of Wednesday, June 13, 2018, the 64th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. A new recruitment website can be visited here. Learn more…

On May 16, 2018, the 60th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. On March 26 - 29, Gabby Fortier, Clinical Research Associate, monitored the clinical research site. A new recruitment website can be visited here. Learn more…

On April 6, 2018, the 55th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. On March 26 - 29, Gabby Fortier, Clinical Research Associate, monitored the clinical research site. A new recruitment website can be visited here. Learn more… | Visit the Recruitment Website

On March 28, 2018, the 50th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. A new recruitment website can be visited here. On March 26 - 29, Gabby Fortier, Clinical Research Associate, will monitor the site. Learn more… | Visit the Recruitment Website

On January 30, 2018, the 38th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Learn more...

On February 12, 2018, the 42nd of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. A new recruitment website can be visited here. Learn more...

Adult military veterans who experienced trauma while in military service are needed for a research study. Study volunteers will complete 17 outpatient study visits over 12 weeks and a 6-month follow-up visit. The study will evaluate the effects of an investigational drug. Eligibility is determined by medical evaluation and modest compensation for participation is provided. All study visits occur at Scottsdale Research Institute. For more information, email This email address is being protected from spambots. You need JavaScript enabled to view it. (SRI).

On November 14, 2017, the 32nd of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Learn more...

On October 26, 2017, the 30th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Learn more...

On September 20, 2017, the 27th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Learn more...

Adult military veterans who experienced trauma while in military service are needed for a research study. Study volunteers will complete 17 outpatient study visits over 12 weeks and a 6-month follow-up visit. The study will evaluate the effects of an investigational drug. Eligibility is determined by medical evaluation and modest compensation for participation is provided. All study visits occur at Scottsdale Research Institute. For more information, email This email address is being protected from spambots. You need JavaScript enabled to view it. (SRI).

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As of June 1, 2017, a total of 18 of 76 participants have enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Four new participants have enrolled since May 4, and participant screening is ongoing. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans.

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As of May 4, 2017, a total of 14 of 76 participants have enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Seven new participants have enrolled since April 10, and participant screening is ongoing. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans.

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On March 13, March 15, and March 30, 2017, the fourth, fifth, and sixth participants were enrolled at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. This clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans.

On March 10, before enrolling a single subject, Johns Hopkins University elected to not participate as a clinical trial site for this study. JHU researchers wanted to focus just on the science but MAPS felt it necessary to focus both on the science and on the politics of the quality of NIDA's marijuana and on ending NIDA's monopoly on the supply of federally legal marijuana for FDA-regulated research. The funding agency, the Colorado Department of Public Health and Environment, signed a new contract with MAPS with SRI in Phoenix being the sole site where all subjects will now be recruited. Learn more...

To maintain transparency to the public and to ensure the reporting of accurate information, MAPS has released the results of the five rounds of secondary analytical testing of the chemical composition of NIDA cannabis. Read the statement...

On February 9 and February 22, 2017, the second and third participants in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans self-administered treatment at the Scottsdale Research Institute (SRI) in Phoenix, Ariz. The second participant was enrolled on February 7, and the third participant was enrolled on February 17. This clinical trial will evaluate the safety and efficacy of four different potencies of marijuana to manage symptoms of PTSD in 76 U.S. veterans. Researchers have screened 131 candidates to date for participation this study. Learn more...

On February 6, 2017, the first participant in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans received cannabis at the Scottsdale Research Institute (SRI) in Phoenix, Ariz. This is the first time this investigational drug has been dispensed to a participant in the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored clinical trial to evaluate the safety and efficacy of four different potencies of marijuana to manage symptoms of PTSD in 76 U.S. veterans.

By exploring the effectiveness of a variety of marijuana potencies, the study seeks to generate research data comparable to what veterans in medical marijuana states currently use. Results will provide vital information on marijuana dosing, composition, side effects, and areas of benefit to clinicians and legislators considering marijuana as a potential treatment for PTSD.

Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania’s Perelman School of Medicine, oversees the two separate study sites as Coordinating Principal Investigator (PI). Bonn-Miller states, “As this is the first placebo-controlled trial of cannabis for PTSD, we are breaking important ground needed to identify improved treatment options for veterans with PTSD.”

Half of the subjects will be enrolled at SRI in Phoenix, Ariz., led by Co-Investigator/Site PI Sue Sisley, M.D., and the other half at Johns Hopkins University in Baltimore, Maryl., led by Co-Investigator/Site PI Ryan Vandrey, Ph.D. Participant screening commenced on January 2, 2017, at SRI, and the first participant was officially enrolled on February 3. Johns Hopkins University commenced screening on January 19. Learn more...

On January 2, 2017, the first in-person participant screening was conducted by researchers at the Phoenix, Ariz., site for our upcoming clinical trial of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. This study is a multi-site Phase 2 drug development trial led by Coordinating Principal Investigator (PI) Marcel Bonn-Miller, Ph.D., with half of the 76 participants treated at the Johns Hopkins University site led by Site PI Ryan Vandrey, Ph.D., and the other half treated at the site in Phoenix, Ariz., led by Site PI Sue Sisley, M.D. We are currently recruiting participants across both sites. Learn more...

On October 3, 2016, researchers at the Phoenix, Ariz., site of our upcoming trial of smoked marijuana for symptoms of PTSD in U.S. veterans began screening participants. On September 29, the Phoenix site received the final delivery of study supplies, including the pipes that participants will use for self-administering marijuana. Former Clinical Research Associate Ben Shechet of MAPS Public Benefit Corporation (MPBC) has transitioned his role to become the new Study Coordinator for our study site in Phoenix.

On August 25, 2016, Site Principal Investigator Sue Sisley, M.D., received the first shipment of marijuana from the National Institute on Drug Abuse (NIDA), at the Phoenix, Ariz., site of our upcoming trial of smoked marijuana for symptoms of PTSD in U.S. veterans. The marijuana arrived in dried bulk form, and will be analyzed by a secondary DEA-licensed laboratory for potency, mold and yeast testing. We currently expect to begin enrolling participants in September.

On August 10, 2016, the National Institute on Drug Abuse (NIDA) approved the Scottsdale Research Institute's official request to order 6.3kg of marijuana to be used by the Phoenix, Ariz., study site in our upcoming study of medical marijuana for posttraumatic stress disorder (PTSD) in U.S. veterans. Multiple marijuana strains were requested, featuring varying levels of THC and CBD per strain, including high THC, high CBD, balanced THC/CBD, and placebo. On July 22, an independent Institutional Review Board (IRB) approved the fifth protocol amendment for the Scottsdale Research Institute's portion of the study, which included changes to clarify several study procedures and adjust study measures. On August 1, the amendment was submitted to the FDA, and to the Drug Enforcement Administration (DEA) on August 2. We will begin screening study participants after NIDA provides a scheduled delivery date for the marijuana. Learn more...

From June 6-16, 2016, a series of investigator meetings and initiation visits took place in preparation for our upcoming study of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. Principal Investigators, study coordinators, and study physicians met in Palo Alto, CA, Baltimore, MD, and Phoenix, AZ, to discuss study procedures, receive training on the electronic platforms to be used in the study, and review protocols for recruitment, enrollment, and study publicity. Discussions at these meetings led to an amendment to the study protocol to clarify several study procedures and adjust study measures. Once the amendment has been approved by the Institutional Review Boards (IRBs) at the Scottsdale Research Institute (Phoenix) and Johns Hopkins University (JHU), we will be able to begin recruiting and enrolling participants. We currently expect that this study will begin in August 2016.

On April 19, 2016, the U.S. Drug Enforcement Administration (DEA) formally approved the first-ever randomized controlled trial of whole plant medical marijuana (cannabis) as a treatment for PTSD in U.S. veterans. The DEA’s approval marks the first time a clinical trial intended to develop smoked botanical marijuana into a legal prescription drug has received full approval from U.S. regulatory agencies, including the DEA, FDA, and Institutional Review Boards (IRBs) at the University of Pennsylvania, Johns Hopkins University, and the Copernicus IRB. The randomized, blinded, placebo-controlled study will test the safety and efficacy of botanical marijuana in 76 U.S. military veterans with treatment-resistant PTSD. The study is funded by a $2.156 million grant from the Colorado Department of Public Health and Environment (CDPHE) to MAPS, which is sponsoring the study. MAPS’ study protocol will be replicated using vaporization by the Canadian medical marijuana producer Tilray, and by the University of Sydney using Tilray extracts in orally administered capsules. View the press release

The Scottsdale Research Institute is searching for a full-time Study Coordinator for the MAPS-sponsored Phoenix, Ariz., study site of our upcoming clinical trial of marijuana for symptoms of PTSD in U.S. veterans. Starting May 1, 2016, this position is responsible for the professional execution of clinical research activities under the direction of Site Principal Investigator Sue Sisley, M.D. For information about requirements for this position and application instructions, visit maps.org/careers. We are currently anticipating this study to begin in June 2016. 

On February 20, 2016, Sue Sisley, M.D., gave a presentation to commissioners of the American Legion in Washington, D.C., about MAPS’ efforts to initiate our clinical trial of medical marijuana for PTSD in U.S. veterans. The talk, titled “Barriers to Researching Medicinal Marijuana,” was presented to the American Legion’s Veterans Affairs and Rehabilitation Commission, TBI and PTSD Committee, as part of their 2016 conference. "I have heard great feedback from the American Legion commissioners who attended saying they felt that it was incredibly successful," reports Dr. Sisley. "They did not believe any issue related to marijuana would be so warmly embraced. They kept thanking me for opening their eyes to a very legitimate injustice of science being shackled by politics."

On January 14, 2016, officials from the local field office of the U.S. Drug Enforcement Administration (DEA) completed their inspection of the Johns Hopkins University trial site in Baltimore, Maryland, for our upcoming study of smoked marijuana for symptoms of PTSD in U.S. veterans. The DEA officials found no issues with the site. The protocol is now awaiting federal DEA approval. The study protocol will be cleared by the Institutional Review Board at Johns Hopkins upon DEA approval. This study is a multi-site Phase 2 drug development trial led by Coordinating Principal Investigator (PI) Marcel Bonn-Miller, Ph.D., with half of the 76 participants treated at the Johns Hopkins site led by Site PI Ryan Vandrey, Ph.D., and the other half treated at a site in Phoenix, Arizona, led by Site PI Sue Sisley, M.D. Renovations and construction at the Phoenix site are expected to be completed in February 2016, followed by DEA inspections. Once the DEA approves the study, we will be able to finalize the contact with the state of Colorado to receive funding, and then order the marijuana for the study from the National Institute on Drug Abuse (NIDA).

On November 2, 2015, the protocol for our upcoming study of smoked marijuana for symptoms of PTSD in 76 U.S. military veterans was submitted for approval to the U.S. Drug Enforcement Administration (DEA). This is the final approval needed for the study before we initiate the study and prepare for participant recruitment. Participants will be U.S. veterans, men or women, aged 18 or older with a diagnosis of PTSD that has not improved after trying either medication or psychotherapy. This study will take place in two locations, one at a private practice office in Phoenix, Ariz., led by Site Principal Investigator (PI) Sue Sisley, M.D., and the other at Johns Hopkins University, led by Site PI Ryan Vandrey, Ph.D. The Institutional Review Board at Johns Hopkins granted conditional approval for the study on September 22, pending final approval by the DEA. This study will be sponsored by MAPS and funded by a $2.1 million grant from the Colorado Department of Public Health and Environment. The Coordinating Investigator for this study is Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania.

On September 25, 2015, the Institutional Review Board (IRB) at Johns Hopkins University approved the protocol design for our upcoming study of smoked marijuana for symptoms of PTSD in 76 U.S. military veterans. The IRB will issue final approval for the study after the U.S. Drug Enforcement Administration (DEA) grants the Schedule I license for the study site in Phoenix, Ariz., and the study is listed on clinicaltrials.gov. The DEA will review the Phoenix study site when construction of the site is complete, and has already approved the specific refrigeration and security systems that we will use to store the study marijuana at the Phoenix site. The Principal Investigator (PI) for this study is Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania. The Johns Hopkins study site is led by Site PI Ryan Vandrey, Ph.D., and the Phoenix site by Site PI Sue Sisley, M.D.

On March 31, 2015, the National Institute on Drug Abuse (NIDA) provided MAPS with information about the cost and availability of marijuana for our planned study of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. It took over a year for NIDA to provide this information after MAPS received our first approval from the U.S. Department of Health and Human Services to purchase marijuana from NIDA in March 2014. Currently, NIDA has three of the four varieties of marijuana we requested; we have asked whether they will also be able to provide an additional variety with a balanced THC/CBD ratio and higher concentrations of THC and CBD than NIDA currently lists as available. On March 11, the Institutional Review Board at the University of Pennsylvania, where Coordinating Principal Investigator (PI) Marcel Bonn-Miller, Ph.D., is located, approved the study protocol. On March 17, an Independent Review Board approved the study for the Arizona site lead by Co-Investigator/Site PI Sue Sisley, M.D. Dr. Sisley will apply for her Schedule I license from the Drug Enforcement Administration once we find a suitable Arizona location. On March 26, the Institutional Review Board at Johns Hopkins University, for the site lead by Co-Investigator/Site PI, Ryan Vandrey, Ph.D., deferred approval for the study, pending revisions to a study measure. The revisions were submitted for review on April 9. Once all approvals are received and the study initiation visits are conducted, the study will be cleared to proceed. Learn more...

On February 25, 2015, in a letter dated February 11, the U.S. Public Health Service (PHS) cleared the revised protocol for our planned study of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. The first historic approval from PHS for the study came in March 2014. The protocol was amended for our successful grant to the Colorado Department of Public Health and Environment, which has awarded more than $2.1 million to MAPS for the study. The revised protocol includes an additional research site at Johns Hopkins University led by Co-Investigator and Site Principal Investigator (PI) Ryan Vandrey, Ph.D.; a private practice site for Co-Investigator and Site PI Sue Sisley, M.D.; the addition of Marcel O. Bonn-Miller, Ph.D., as Coordinating PI; and the addition of Co-Investigator Paula Riggs, M.D., to help ensure scientific integrity for the study. We are currently waiting for NIDA to provide information about the cost and availability of marijuana needed for the study. In addition, the study has been submitted for approval to the U.S. Food and Drug Administration and three Institutional Review Boards. The Johns Hopkins group has already received its Schedule I license from the Drug Enforcement Administration; Dr. Sisley will apply after the other approvals are in place. Once these final approvals are received, the study will be cleared to proceed.

On January 30, 2015, the Colorado Department of Public Health and Environment (CDPHE) approved our request for $156,000 in additional funding for our planned multi-site study of smoked marijuana for PTSD in 76 U.S. veterans. These funds, from Colorado's Medical Marijuana Research Grant Program, will supplement the $2 million grant awarded to MAPS by CDPHE on December 17, 2014, and will be used for administrative costs, salary support, and facility fees. Meanwhile, we're still waiting for the National Institute on Drug Abuse (NIDA) to inform us when, which varieties, and at what cost it will make marijuana available to us for this study, even though we were approved for access to NIDA marijuana in March 2014. Principal Investigator Sue Sisley, M.D., will be honored with the Americans for Safe Access (ASA) Researcher of the Year Award at the National Medical Marijuana Unity Conference in Washington, DC, on March 30, 2015.

On December 17, 2014, the Colorado Department of Public Health and Environment (DPHE) awarded MAPS a $2 million grant for our planned study of marijuana for symptoms of posttraumatic stress disorder (PTSD) in 76 U.S. veterans. Colorado's Medical Marijuana Scientific Advisory Council recommended that MAPS receive the grant on November 24. MAPS was chosen to receive the largest of eight grants awarded by DPHE at Wednesday's meeting. All of the other grantees are major research universities. "As the very first public funding that MAPS has ever received in our 28½ year history, the award clearly shows that attitudes are improving about research into the therapeutic benefits of Schedule I drugs," said Rick Doblin, Ph.D., MAPS Founder and Executive Director. "It's a big step forward for cannabis science and medicine." Despite the award and prior Food and Drug Administration (FDA) and Public Health Service (PHS) approval, the study still faces obstacles, most importantly the lack of information from the National Institute on Drug Abuse (NIDA) about when they will be able to provide the marijuana for the study. Learn more...

On October 14, 2014, MAPS submitted a proposal to the Colorado Department of Public Health and Environment requesting $2 million for our planned study of marijuana for symptoms of PTSD in 76 U.S. veterans. The state of Colorado has $9 million available for marijuana research, and the response to our submission is expected in late November or December. The National Institute on Drug Abuse (NIDA) estimates that they will be able to provide the marijuana for our study in January 2015. The study is the first randomized controlled trial (RCT) to test the therapeutic potential of smoked marijuana and its components as a treatment for PTSD.

This will be a two-site study led by Principal Investigator Sue Sisley, M.D., who will conduct her portion of the study in her private practice office in Arizona or at Arizona State University, and a second Principal Investigator, Ryan Vandrey, Ph.D., who will conduct his portion of the study at Johns Hopkins University in Baltimore, MD. On September 25, veterans and medical marijuana advocates spoke to the Arizona Board of Regents in favor of Dr. Sisley, encouraging ASU to host part of the study there. Dr. Sisley is currently in discussions with ASU about the possibility of hosting the study there. Watch: Arizona’s Channel 12 News reports

Marcel Bonn-Miller, Ph.D., of the VA National Center for PTSD will serve as Coordinating Principal Investigator, and Paula Riggs, M.D., of the University of Colorado, Denver will serve as Senior Scientific Advisor. Blood analysis will be conducted at the University of Colorado, Boulder. MAPS will be responsible for FDA approval, project and data management and monitoring, drug accountability, and ensuring Good Clinical Practice (GCP) guidelines are followed throughout the study. “It is a major triumph that we have built this outstanding team of top researchers, partnering with national experts at the VA, NIDA, Johns Hopkins, and the University of Colorado,” said MAPS executive director Rick Doblin, Ph.D. “The obstacles we’ve faced have ultimately strengthened the study.” Learn more | Read the RFA

A petition launched on Change.org by Arizona veteran Ricardo Pereyda has gathered over 105,000 signatures in support of MAPS and Dr. Sue Sisley’s efforts to initiate medical marijuana research in Arizona. Launched on July 10, the petition reached 100,000 signatures in just 21 days. Sign the petition…
            
The public outcry against Dr. Sisley’s dismissal from the University of Arizona has reached a national audience. On June 27, the University of Arizona notified Dr. Sisley that her university appointments would be terminated as of September 26. On July 28, the University of Arizona expectedly denied Dr. Sisley’s appeal for reinstatement, forcing Dr. Sisley to seek a new location for the study. On July 30, the University of Arizona proposed a replacement investigator, ignoring MAPS’ repeated public statements that we will stand behind Dr. Sisley wherever the study is ultimately conducted.
            
MAPS and Dr. Sisley are seeking a new location for the study within Arizona with reinstatement at the University of Arizona no longer a possibility. Multiple universities outside Arizona have already offered to host the study.

On July 22, Dr. Andrew Weil, founder of the Arizona Center for Integrative Medicine at the University of Arizona, wrote a letter to University of Arizona President Dr. Ann Weaver Hart expressing his support for Dr. Sisley’s work. "Dr. Sisley has passionately chosen her professional obligation to patients over political pressure; she has chosen science over dogma; and has chosen integrity over censorship. This is the type of individual any University should want on their faculty."
            
Dr. Sisley has been working with MAPS since 2010 to initiate a study of the safety and effectiveness of whole plant marijuana, smoked or vaporized, in 70 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).

      

• CNN with Sanjay Gupta: University Drops Marijuana Researcher
           
• NBC: Pot Researcher Firing Unleashes Rising Veteran Backlash
           
• FOX 10 Phoenix: Vets Rally Behind Pot Researcher Set To Be Fired By the UofA
           
• Military Times: Pot-for-PTSD Researcher Denied Reinstatement

On July 11, 2014, MAPS founder and executive director Rick Doblin, Ph.D., sent a second letter to Caroline Garcia, Associate Vice President for Research at the University of Arizona, reiterating MAPS’ support of Dr. Sue Sisley. In the letter, Doblin clarifies that MAPS and Dr. Sisley will move the study to another university if she is not reappointed at the University of Arizona, and will not accept the university’s proposal for an alternate Principal Investigator. See below for the text of the letter.

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To Caroline Garcia, Associate Vice President for Research, University of Arizona,

Caroline, +++

You wrote me today at 7:53 PM ET: “Thank you very much for your response. I have shared your response with our senior leadership.  We will move forward as we discussed yesterday to propose a new University of Arizona Principal Investigator for this research study.”

I thought my prior response was clear, perhaps not. Dr. Sisley would make an ideal Principal Investigator.  If Dr. Sisley’s appeal to the University of Arizona to be reinstated is not successful, MAPS will not replace her as the PI but will move the study elsewhere. Your replacing Dr. Sisley may constitute a breach of our contract and we will be seeking advice of counsel regarding that issue.

I appreciate your continued efforts to keep the University of Arizona involved in the conduct of MAPS’ marijuana/PTSD study, in accordance with our fully executed Clinical Trial Agreement.  I believe that we are in agreement that this is a pioneering study that would generate much-needed and potentially life-saving data that has the potential to significantly impact the health of veterans and others suffering from chronic, treatment-resistant posttraumatic stress disorder (PTSD).

Frustratingly, NIDA is by law required to have an adequate and uninterrupted supply of marijuana for research, which it has failed to do.  As a result, we can’t start for another half year until NIDA can provide the marijuana that it claimed in writing over three years ago (January 14, 2011) that it could make available for an approved protocol.  While we are waiting on NIDA, there is time for Dr. Sisley’s appeal process to run its course without delaying the start of our study.

We hope Dr. Sisley’s appeal process resolves successfully with the reversal of her termination. Dr. Sisley has devoted a great deal of her time over many years to bring this project to this point of FDA, IRB and PHS/NIDA approval. If there is anything I can do to assist in the review of Dr. Sisley’s appeal, please let me know.

Sincerely,

Rick Doblin, Ph.D.(Ph.D., Public Policy, Kennedy School of Government, Harvard University)
MAPS Executive Director

On June 30, 2014, the University of Arizona fired Dr. Sue Sisley, the Principal Investigator (PI) of our planned study of marijuana for symptoms of PTSD in 70 U.S. veterans. The University of Arizona offered no explanation for their decision, informing Dr. Sisley that her academic appointment would be terminated as of September 26. On July 10, Caroline Garcia, Associate Vice President for Research at the University of Arizona, told MAPS Executive Director Rick Doblin that the university supports the study and proposed an alternate PI. On July 11,  Doblin sent a letter to Garcia stating that MAPS will stand behind Dr. Sisley in her appeal and wherever the study is ultimately conducted.

Dr. Sisley is now appealing her dismissal with legal representation by Jason Flores-Williams. Unless Dr. Sisley is reinstated, she cannot conduct the study at the University of Arizona and will need to find a new location. The controversy surrounding the University of Arizona’s decision has received widespread media attention including the Los Angeles Times, Reuters, AZ Central, and USA Today, plus upcoming reports from CNN and The New York Times.

The U.S. Department of Health and Human Services approved the study in March 2014, marking the first time in over 22 years that MAPS-sponsored researchers studying the benefits of whole plant marijuana for a specific medical condition were approved to purchase marijuana from the National Institute on Drug Abuse (NIDA), which maintains a monopoly on the supply of marijuana available for research in the U.S. The study also has approval from the U.S. Food and Drug Administration and the Institutional Review Board at the University of Arizona.

The University of Arizona firing of Dr. Sisley doesn’t yet delay the study from starting since NIDA has informed MAPS in writing that it cannot provide the marijuana we need containing the cannabinoid, cannabidiol (CBD) until about January 2015. MAPS and Dr. Sisley still have about six months to resolve the issue of where the study will be conducted.

Sign the petition on Change.org.

On April 17, 2014, the National Institute on Drug Abuse (NIDA) informed MAPS that it does not have the marijuana needed for our study. This was completely unexpected as it contradicts NIDA’s written claim over three years ago that they did have a supply of marijuana containing the balanced THC/CBD ratio needed for our study. We designed our protocol around that variety in order to gather information about the relative risks and benefits of THC and CBD in veterans with chronic, treatment-resistant PTSD.

NIDA’s written statement three years ago that it could supply us with the marijuana we requested was very convenient for the agency. NIDA’s claim was the reason we lost our lawsuit against the Drug Enforcement Administration (DEA) for rejecting a DEA Administrative Law Judge’s recommendation that it would be in the public interest for the DEA to license University of Massachusetts Prof. Lyle Craker to grow marijuana under contract to MAPS for federally regulated research. The U.S. First Circuit Court of Appeals accepted NIDA’s and the DEA’s claims that NIDA had an adequate supply.

On May 9, after a three-week delay, NIDA informed us that they will have to grow the marijuana we need for our protocol and that it will not be available until sometime in the fall of 2014, on an unknown date and at an unknown price. NIDA is required under the Controlled Substances Act of 1970 to provide a “continuous and uninterrupted supply” of marijuana for research, which they have now admitted to failing to provide. NIDA is currently the only source of marijuana legal for use in federally regulated research.

On March 14, MAPS finally received permission to purchase marijuana from NIDA from the U.S. Department of Health and Human Services’ Public Health Service (PHS) reviewers, after 22 years trying to obtain marijuana for federally approved medical marijuana drug development research. It now looks like there will be another delay of at least half a year while we wait for NIDA to produce the marijuana we need for our study.

On March 14, 2014, in an historic shift in federal policy, the U.S. Department of Health and Human Services granted permission for MAPS to purchase marijuana from the National Institute on Drug Abuse (NIDA) for our planned study of marijuana for symptoms of PTSD in U.S. veterans. We have been working for over 22 years to start marijuana drug development research, and this is the first time we’ve been granted permission to purchase marijuana from NIDA, the sole provider of marijuana for federally regulated research in the United States. We have been denied permission to purchase NIDA marijuana for two prior FDA- and IRB-approved studies and one laboratory vaporizer study, preventing them from taking place. It took over four and a half months for reviewers at the Public Health Service (PHS) to respond to our October 24, 2013, protocol resubmission, after initially rejecting the protocol on September 16, 2011. The study still requires final approval from the U.S. Drug Enforcement Administration, for which Principal Investigator Dr. Sue Sisley’s Schedule I application was submitted on March 25.  We are optimistic the DEA will approve the study in a timely manner. The study will also require funding support. "When it comes to researching the medical potential of Schedule I drugs," said MAPS Founder Rick Doblin, "Privately funded medical marijuana drug development research has been the last domino to fall." The tide has turned for medical marijuana research, and we look forward to starting the study.

View the approval letter from HHS

On March 10, 2014, the Arizona House of Representatives passed HB 2333, a bill that could have provided up to $250,000 in funding for our planned study of marijuana for symptoms of PTSD in U.S. veterans. The funds would have come from over $7.5 million in fees collected from the Arizona medical marijuana program. The possibility for the study to receive this funding disappeared, however, when Arizona State Senator Kimberly Yee (R-Phoenix), who chairs the Senate Committee on Education, blocked the bill by refusing to put it on her committee’s agenda before the March 20 deadline. Senator Yee said that she prefers the funds to be used for anti-drug education. With these funds now unavailable, we will still need funding to make the study possible.

Download the press release.

A Food and Drug Administration (FDA) and University of Arizona Institutional Review Board (IRB)-approved protocol for a study of marijuana for symptoms of PTSD in U.S. veterans, sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), has been on hold for over 3½ months, as researchers wait for the PHS to respond to their request to purchase marijuana for the study.

 

On February 13, 2013, MAPS Executive Director Rick Doblin, Ph.D., once again contacted the U.S. Department of Health and Human Services reminding the agency that more than three and a half months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approvedstudy of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization,” Doblin writes, “Can you help me understand why the Obama Administration still insists on obstructing medical marijuana research?

Subject: More than 3 1/2 Months for PHS Marijuana/PTSD Protocol Review-2/13/14 NYTimes op-ed on federal obstruction of research

Date: February 13, 2014
From: Rick Doblin, MAPS
To: Sarah Wattenberg, HHS

Sarah, +++

I imagine that you aren’t too happy to have the unenviable job of being the point person for obstructing privately-funded, FDA and IRB-approved medical marijuana research.

It’s now more than 3 1/2 months since Oct. 24, 2013, when MAPS submitted our FDA and IRB-approved protocol to you for the PHS review. As the saying goes, “Justice delayed is justice denied.”  MAPS is the conservative wing of the medical marijuana movement in that we are focused on conducting FDA-regulated research but our efforts are not welcomed.

Today’s NYTimes had an op-ed discussing the federal obstruction of medical marijuana research. Unfortunately from my perspective, the article focuses on rescheduling marijuana to facilitate research, which isn’t necessary or likely, and doesn’t mention the PHS protocol review process which is the key obstruction along with the NIDA monopoly.

We’re doing our best to focus public attention on the PHS review process but we have been less successful than I have hoped. I anticipate greater success in the future illuminating the problematic PHS review process.  We are considering bringing some vets to DC to protest the delays in the PHS review process but we’ll hopefully receive some favorable news from you before we organize the protest.

Do you have any idea when this interminable PHS review process will come to a conclusion, with either permission or rejection to purchase NIDA marijuana?  I’m aware, as I am sure you are also aware, that even if we pass the PHS review, we still need to obtain DEA approval for the protocol before we can start the study.  About 2200 vets have committed suicide since we submitted our protocol to you for review. Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization, can you help me understand why the Obama Administration still insists on obstructing medical marijuana research and hasn’t yet ended the PHS review process?

puzzled,

Rick

Over three years ago, on December 15, 2010, the U.S. Food and Drug Administration (FDA) approved the protocol for our planned study of marijuana for PTSD in U.S. veterans, pending information about the source of the marijuana to be used in the study. Due to the ongoing Drug Enforcement Administration-protected monopoly held by the National Institute on Drug Abuse on marijuana for research, over three years later we’ve still been unable to obtain marijuana for the study. In their January 27, 2014, letter, the FDA asked MAPS to respond within 30 days if we still wish to proceed with the study. In his February 17 response, MAPS Executive Director Rick Doblin, Ph.D., writes, “We still do plan on responding to the clinical hold deficiencies but we can’t say exactly when we will have located a supply of marijuana for the study.” We have now been waiting almost four months for a response from the Public Health Service to our October 24, 2013, protocol resubmission.

Update: On March 5, the FDA informed MAPS that our IND will remain active for another year.

On January 24, 2013, MAPS Executive Director Rick Doblin, Ph.D., sent an email to the U.S. Department of Health and Human Services reminding the agency that three full months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. "We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues," Doblin writes "This delay is itself an obstruction of medical marijuana drug development research."

Subject: 3 Months for PHS Marijuana/PTSD Protocol Review, Chicago Tribune column

Date: January 24, 2014
From: Rick Doblin, MAPS
To: Sarah Wattenberg, HHS

Sarah,

Today completes the third month since Oct. 24, 2013, when we submitted to you our FDA and IRB-approved protocol for PHS review. We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues. This delay is itself an obstruction of medical marijuana drug development research.

In our letter of Oct. 24, 2013, MAPS also requested that HHS end the PHS protocol review process for privately-funded medical marijuana drug development studies. PHS review is designed for evaluating grant applications for government funding of basic science. PHS review is not appropriate for privately-funded FDA drug development studies designed to meet FDA standards but not to gather basic science information. The PHS review exists only because of NIDA's DEA-protected monopoly. Rather than the PHS review, NIDA should sell its marijuana at cost to all sponsors of research approved by FDA, DEA, IRB and state authorities. Those agencies already regulate privately-funded research with all other Schedule 1 drugs, without PHS involvement.

As you may have noticed, a column in yesterday's Chicago Tribune by Steve Chapman, a member of the Tribune's editorial board, called on President Obama to end the PHS medical marijuana protocol review process. Since it hasn't ended yet, I look forward to working with you to find a way to start this much-needed study.

sincerely,

Rick

On October 25, 2012, the Institutional Review Board (IRB) at the University of Arizona notified Principal Investigator Sue Sisley, M.D., that they had approved the protocol for our planned study of marijuana for symptoms of PTSD in 50 U.S. veterans. The third and final IRB review took place on October 23. The Food and Drug Administration approved the protocol in April 2011, though the study has been blocked by the National Institute on Drug Abuse since September 2011. We are now preparing to resubmit the protocol and study documents, hoping that approval from both the IRB and the FDA will persuade NIDA to sell us the marijuana needed for the study.

On October 12, 2012, MAPS and Principal Investigator Sue Sisley, M.D., resubmitted to the Institutional Review Board (IRB) at the University of Arizona the revised protocol, informed consent, and other documents for our study of marijuana for veterans with PTSD. The study aims to explore the safety and effectiveness of smoked or vaporized marijuana for symptoms of PTSD in 50 veterans with chronic, treatment-resistant PTSD. The FDA cleared the study on April 28, 2011, which has since been blocked by the National Institute on Drug Abuse/Public Health Service’s September 16, 2011, refusal to sell researchers the marijuana needed for the study. We are hopeful that approval from the IRB will increase pressure on the NIDA/PHS reviewers to evaluate the protocol on the basis of science rather than politics. NIDA/PHS approval would allow us to submit the protocol to the DEA for final approval, and allow us to continue working to develop more effective treatments for veterans with PTSD. In their August 31 letter, the IRB indicated that they were satisfied with the overall study design, but required several minor changes regarding subject safety. The revised protocol addresses these requested changes, including a detailed safety plan for subjects participating in the study and revised informed consent forms.

On August 31, 2012, the Institutional Review Board at the University of Arizona responded to our July 30 submission of the protocol for our planned study of smoked or vaporized marijuana for 50 U.S. veterans with chronic PTSD. After a meticulous review, the IRB committee sent Principal Investigator Sue Sisley, M.D., a list of nine issues to address, requiring relatively minor changes to the protocol and informed consent documents. The IRB’s letter indicated that they were satisfied with the key protocol design elements. MAPS and Dr. Sisley responded to the IRB’s comments on September 14, and we are hopeful that the protocol will be approved at the upcoming meeting of the IRB on September 25. Thousands of U.S. veterans are using marijuana to treat their PTSD symptoms despite the lack of any controlled research into its safety and effectiveness. Several medical marijuana states use this lack of research as justification for refusing to allow physicians to recommend marijuana for PTSD. Our protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to the National Institute on Drug Abuse/Public Health Service’s refusal to sell researchers the marijuana needed for the study. One of the issues raised by the NIDA/PHS reviewers in their rejection was that the protocol had not yet received IRB approval, although IRB approval is not required for NIDA/PHS to accept a protocol. If NIDA/PHS still refuses to allow us to conduct the study once both the FDA and the IRB have cleared it, the political motivations behind the federal marijuana research blockade will be even more apparent, as will the need for state-level reform.

AZ Family describes Arizona’s current struggle with medical marijuana due to political obstacles. The public of Arizona petitioned the Department of Health Services to add PTSD, migraines, anxiety, and depression to the list of eligible conditions for medical marijuana, but all of the proposals were turned down due to lack of research. Dr. Sue Sisley of Arizona observes, "I don't know any members of the public that are satisfied with the fact that science is being shackled by politics."

Watch the segment online here.

As we prepare to watch nearly 100 medical marijuana dispensaries open across the state, efforts to expand the list of conditions eligible for cannabis keep hitting obstacles.

Dr. Sue Sisley is an advocate for medical marijuana.

"This drug deserves its opportunity to go under the rigors of high-level science," Sisley said.

Sisley wonders if marijuana will ever be fully understood in the medical community. Since it's considered illegal by the federal government, she says it's difficult to do the needed research.

"Is marijuana useful for what conditions? What dosage works the best? What delivery method? Is it better to smoke or vaporize or use edibles? All those things are up in the air and nobody knows how to answer them now," she said.

Last month, the public petitioned the Department of Health Services to add migraines, PTSD, anxiety and depression to the list of diagnoses eligible for medical marijuana. All were turned down.

"The research isn't there to say whether marijuana is beneficial or harmful when it comes to the petitioned debilitating medical conditions," explained Health Director Will Humble.

Humble, who shot down the additional conditions, maintains without clinical trials or observational studies, he can't in good conscience expand our list.

"I just can't make that leap to say, well, because the data is lacking and it's difficult to do studies, I'm going to add it anyway in hopes that it's beneficial," he said.

Sisley maintains, "There is a tremendous amount of anecdotal experience, some published, some not, that suggests that this is a very useful intervention for patients."

Both opponents and supporters seem to agree more scientific research is needed. But will it ever happen? Humble contends, "It makes it difficult to do studies on drugs that are schedule one. Not impossible but difficult."

"The clinical trials that he's demanding from this community, randomized controlled trials, high-level observational studies, those studies don't happen for free," Sisley said. "They're very expensive."

Arizona's medical marijuana surplus fund has $5 million. But it's off limits.

"If I wanted to I still couldn't do it because the act requires that it be used to administer the act, doesn't talk about research," Humble said.

It's a frustration for doctors who see more potential benefits of cannabis.

"I don't know any members of the public that are satisfied with the fact that science is being shackled by politics," Sisley said.

Sleep disorders and skin conditions are the latest two diagnoses being petitioned to add to the list. A ruling on those aren't expected until January.

On July 30, 2012, MAPS and Sue Sisley, M.D., submitted the protocol for our FDA-approved study of marijuana for veterans with PTSD for review by the University of Arizona Institutional Review Board (IRB). The IRB review is scheduled for August 28. MAPS also submitted a detailed cover letter explaining our rationale for various elements of the protocol design.

The protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to NIDA’s refusal to sell researchers the marijuana needed for the study. We will respond to the NIDA/Public Health Service reviewers’ comments if the IRB also approves the study protocol.

On June 2, 2012, the Arizona Medical Association (ArMA) House of Delegates unanimously adopted a resolution (pdf) challenging the National Institute on Drug Abuse’s blockade of medical marijuana research. ArMA’s resolution is yet another pressure point on the federal government's obstruction of medical marijuana research. ArMA resolved that “once the protocol for privately-funded marijuana research has been reviewed and approved by the Food and Drug Administration and relevant Independent Review Board and the practitioner has obtained registration from the Drug Enforcement Administration, the National Institute of Drug Abuse shall, without further evaluation of the research protocol, supply marijuana for the research, at cost, upon the practitioner’s proper application.”

On April 3, 2012, Arizona governor Jan Brewer signed into law a bill prohibiting the use of medical marijuana on the campuses of schools, colleges, and universities in the state. The new law is an example of the current backlash against medical marijuana that is taking place at both the state and federal level across the United States. While the bill was intended to regulate state medical marijuana patients, some administrators at the University of Arizona have suggested that the bill could also apply to federally regulated medical marijuana research. This could prevent MAPS from being able to conduct our FDA-approved study of marijuana for PTSD on the campus of the University of Arizona in Phoenix, where Principal Investigator Sue Sisley, M.D., is planning to conduct the study.

In the study protocol, we propose to explore the safety and effectiveness of smoked and/or vaporized marijuana in 50 U.S. veterans with chronic, treatment-resistant PTSD. We are now seeking clarification on the extent of the new law, which is on shaky legal ground if used to ban federally regulated research. Meanwhile NIDA, which has a monopoly on the supply of marijuana for use in FDA-regulated research, continues to block the study by refusing to sell us the marijuana required for the study.

On September 16, after a delay of four and a half months, the US Department of Health and Human Services informed MAPS that the five NIDA/PHS reviewers had unanimously rejected our planned study of marijuana for veterans with PTSD as currently designed. According to MAPS Executive Director Rick Doblin, Ph.D., the reviewers offered contradictory critiques, misunderstood key protocol design elements, requested expensive and tangential additions to the protocol, and made unfounded assumptions about the study design, revealing their focus on basic science research and lack of familiarity with drug development research. The reviewers also treated the submission as if MAPS were requesting a government grant for the study rather than using private funds. Even if NIDA does eventually agree to sell MAPS the marijuana, getting to that point will take extensive, time-consuming, and costly negotiations—while veterans continue to suffer.

For a concise summary of the HHS review, see the September 16 HHS cover letter. For MAPS’ detailed, point-by-point response to the HHS review, see the annotated reviewer comments.

Download MAPS’ official press release announcing the HHS rejection.

On April 28, 2011, the revised protocol for our planned study of marijuana for symptoms of PTSD in US veterans was accepted by the FDA, and submitted to the Department of Health and Human Services (HHS) to be reviewed by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). On July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon. The HHS notice came only days before an article about the study in The New York Times (July 18, 2011) made MAPS' marijuana research national news.

On April 28, 2011, the U.S. Food and Drug Administration accepted MAPS' protocol design for our study of marijuana for symptoms of PTSD in war veterans, stating that our revised protocol successfully addresses their previous concerns. Once again, the FDA has demonstrated its willingness to evaluate studies on the basis of scientific merit rather than political partisanship.

Although both MAPS and the FDA are satisfied with the protocol design, we cannot begin the study until passes yet another review process with the National Institute on Drug Abuse/Public Health Service (NIDA/PHS). This redundant review, which may take another year or more, is required solely because NIDA has a monopoly on the supply of marijuana for research, and NIDA/PHS must review the protocol before allowing us to purchase marijuana from the agency. NIDA's mission does not include exploring the potential beneficial uses of marijuana.

MAPS has been pressuring the federal government through hearings, lawsuits, and appeals for over a decade to allow us to grow our own marijuana. The DEA has refused to accept the recommendation of its own Administrative Law Judge that it would be in the public interest for Professor Lyle Craker of the University of Massachusetts, Amherst, to receive a license to grow marijuana for research regulated by the FDA.

Many U.S. veterans already use medical marijuana to deal with their symptoms of PTSD. MAPS is seeking to conduct the first clinical trial testing the use of the smoked or vaporized marijuana plant in PTSD patients. Now the PHS/NIDA will decide if MAPS can obtain marijuana for 50 suffering veterans.

On March 15, 2011, MAPS submitted to the FDA the revised protocol for its planned study of smoked and/or vaporized marijuana for PTSD in war veterans. In a February 9 conference call, the FDA acknowledged that we had successfully addressed their concerns about subjects diverting unused marijuana, and requested that we submit this revised protocol. If after reviewing the revised protocol the FDA decides to allow the study to proceed, the next step will be to move the protocol through a complicated review process with the National Institute on Drug Abuse and the Public Health Service.

On February 3, 2011, the U.S. FDA asked MAPS to provide additional information regarding the protocol for our planned study of the safety and effectiveness of smoked and/or vaporized marijuana for the treatment of PTSD symptoms in war veterans. The agency's principal concerns involved the possibility of subjects giving or selling ("diverting") unused marijuana during or after the study. This is an important point for the FDA given that this study would be the first outpatient marijuana study to be conducted in approximately 30 years.

On February 9, 2011, MAPS and the FDA had a teleconference to discuss these concerns. It was a major success. Prior to the meeting, MAPS prepared responses to each of the seven points raised in the February 3 letter and developed a chart listing of the advantages and disadvantages of several strategies for preventing diversion. We proposed a two-part solution: First, each subject will be given a handheld video camera (the Flip) with which they will record themselves removing the marijuana from its canister (containing one week's supply), using it, and replacing unused material. Study staff will review these videos on a weekly basis prior to giving subjects their next week's marijuana. Second, subjects will be asked to give us the name of a significant other who we can call weekly for independent verification that subjects used the marijuana themselves. If it cannot be verified that subjects used the marijuana themselves, they will be removed from the study.

During the teleconference, the FDA said our approach was reasonable. They indicated that we should submit the revised version incorporating the new safeguards for FDA review. The FDA saw that we were sincere in trying to address the issue of diversion control, and we saw that the FDA was willing to move forward with our study. However, if the FDA approves the protocol, we still need to run the gauntlet of the redundant Public Health Service/National Institute on Drug Abuse review process, which is likely to be much more difficult and much less reasonable than that of the FDA. At the very least, we are one crucial step closer.

On December 15, 2010, the FDA notified MAPS that our planned study of smoked or vaporized marijuana for veterans with chronic, treatment-resistant PTSD had been placed on full clinical hold until we are able to provide specific information about the source, composition, concentration, and manufacturing method of the active and placebo marijuana cigarettes we plan to use. We have requested that the National Institute on Drug Abuse (NIDA) provide the marijuana as a result of the agency’s monopoly on the legal supply of marijuana for use in FDA-approved studies. Despite having submitted the study protocol to NIDA and the Public Health Service (PHS) nearly two months ago, we still have not heard a word about the likely time frame for the NIDA/PHS protocol review.

Fortunately, the FDA has a set a precedent of reviewing and even approving protocol designs before having complete information on the source of the drug. We expect to receive FDA’s protocol critiques very soon. Even if we obtain FDA approval, the protocol must also be approved through the NIDA/PHS review process. In the 1990s, MAPS had two medical marijuana protocols approved by the FDA but rejected by NIDA, preventing the studies from taking place.

On January 14, 2011, an official from NIDA sent an email to MAPS Executive Director Rick Doblin, Ph.D., indicating that the agency does in fact have the various levels of marijuana with delta-9-tetrahydrocannabinol (THC) that we need for our study. The study protocol calls for marijuana with five different concentrations of THC and cannabidiol (CBD): 0% THC (placebo), 2% THC, 6% THC, 12% THC, and 6% THC/6% CBD. NIDA claims that it has marijuana cigarettes of 0.004% (placebo), 2.1%, 5.6%, or 6.7% THC. They also claim that their facility at the University of Mississippi has in stock bulk marijuana containing 12% THC that can be manufactured into cigarettes, and that they can blend different batches to produce cigarettes containing marijuana with 6% THC and between 4% and 6% CBD (despite their initial insistence that they did not have any marijuana with CBD).

NIDA appears to be doing its best to provide what we need for the study, perhaps due to the pressure we have been putting on them through Professor Lyle Craker’s ongoing lawsuit against the DEA seeking a license to grow marijuana for federally regulated research under contract to MAPS.

On December 15, 2010, FDA placed MAPS' study of marijuana for people with PTSD on full clinical hold. (Letter describing study placement on clinical hold.)

On December 15, 2010, FDA placed MAPS' study of marijuana for people with PTSD on full clinical hold. (Letter describing study placement on clinical hold.)

On December 15, 2010, FDA placed MAPS' study of marijuana for people with PTSD on full clinical hold. (Letter describing study placement on clinical hold.)

On Nov. 11, 2010, MAPS’ clinical research team submitted our newest marijuana protocol to the FDA. If approved, the study will gather preliminary information about whether medical marijuana is a safe and efficacious way to manage symptoms of PTSD. The FDA has already requested more information about where we would obtain the marijuana for the study. On Nov. 23, MAPS Executive Director Rick Doblin, Ph.D., wrote to the Chemistry and Physiological Systems Research Branch at the National Institute of Health (NIH)/National Institute on Drug Abuse (NIDA) to inquire about the cost and THC content of NIDA-supplied marijuana. On Dec. 2, we received an email from the agency informing us that NIDA could provide us with three out of the five potencies of marijuana we wish to test. According to the agency, NIDA has placebo marijuana cigarettes (containing just 0.004% THC) and marijuana cigarettes containing 2.1%, 5.6%, and 6.7% THC. It does not, however, have marijuana cigarettes containing 12% THC or the combination of 6% THC/6% CBD, which our protocol requires. NIDA also cautioned us that the THC content of its marijuana deteriorates over time, and that we should ask for updated potency information prior to ordering. On Dec. 3, Rick wrote back to NIDA asking how much it would cost and how long it would take for NIDA to develop marijuana that contained 6% THC/6% CBD and 12% THC. A NIDA representative replied to Rick’s inquiry on Dec. 8, informing him that Mahmoud Elsohy, Ph.D., the director of NIDA’s marijuana project at the University of Mississippi, was out of town and that NIDA would respond in several weeks. Meanwhile, on Nov. 24, a representative from the FDA wrote to MAPS requesting information on behalf of the FDA’s Chemistry, Manufacturing, and Controls (CMC) team. They requested information regarding: (1) the source of the active and placebo marijuana cigarettes, including the name and address of the manufacturer, (2) the complete composition of each strength and technical grade of each excipient (the non-marijuana components of each cigarette), (3) how the specific concentration of THC and CBD in the marijuana plant is achieved, (4) the method of manufacture of the cigarettes, (5) the specifications for each strength and description of the analytical procedures, (6) the certificate of analysis for each strength to be used in the clinical study and the date of manufacture,  and (7) a letter of authorization to NIDA's Drug Master File for marijuana cigarettes. Rick responded to the FDA letting them know that the organization has set a precedent of reviewing and approving protocols before having all the required information for the source of the drug to be used in the study. In such cases, the protocol can be approved, but the study is on clinical hold until the FDA CMC review team is satisfied with the information regarding the drug to be used in the study. The Public Health Service (PHS)/NIDA protocol review process, which is required for all studies seeking NIDA marijuana (but which isn’t required for any of our psychedelic research since we have our own independent source), can take about six months, and it’s likely that the reviewers will have questions about the protocol. After we respond to those questions, it could take another six months for PHS/NIDA to comment on our replies—a process which will repeat until our protocol is either rejected or approved. Until those reviews are completed and NIDA approves the protocol, NIDA will not give MAPS permission to purchase its marijuana and cross-reference its Drug Master File. Therefore, while it is currently impossible for MAPS to provide the information requested by the FDA CMC review team, the FDA should be able to continue with its review.

Julie Holland, M.D., has reviewed the protocol and agreed to be the medical monitor for our newest study of marijuana as a treatment for PTSD. The protocol was submitted to the FDA on Nov. 12, 2010, and on Nov. 17, 2010, MAPS received a new Investigational New Drug number for marijuana: #110513. Dr. Holland recently edited and published The Pot Book, which is a magnificent resource about marijuana. The book is available in the MAPS store and proceeds directly fund MAPS' medical marijuana research mission.

MAPS received an Investigational New Drug identification number for marijuana from the FDA. This is part of our study of marijuana for PTSD.

On Oct. 3, Research and Information Specialist Ilsa Jerome, Ph.D., Clinical Research Associate Berra Yazar-Klosinski, Ph.D., and Executive Director Rick Doblin, Ph.D., finalized the study design for our investigation of marijuana as a treatment for Posttraumatic Stress Disorder (PTSD). We are preparing to submit the protocol and informed consent forms to the FDA by the end of this month. We currently consider marijuana usage to be more useful in treating symptoms of PTSD and requiring regular administration, while MDMA-assisted psychotherapy is aimed at achieving a cure by getting to the core of the problem.

MAPS is preparing a marijuana/PTSD pilot study in veterans of war to be conducted by Principal Investigator Sue Sisley, M.D. in Arizona. The protocol is close to being submitted to the FDA after having been reviewed, critiqued, and revised by several outside experts. The study is being developed in response to anecdotal reports of marijuana being used to alleviate PTSD symptoms. At present, there is no published data from a randomized, placebo-controlled, double-blind study of the risks and benefits of marijuana for chronic PTSD sufferers.

Forty subjects will be randomly allocated to one of four treatment groups. Each subject will be provided with two rolled cigarettes daily, each weighing 0.9 grams, the standard-size marijuana cigarette provided by the National Institute on Drug Abuse (NIDA). The cigarettes will contain either (1) 2% D9-tetrahydrocannabinol (THC), (2) 6% THC, (3) 6% THC and 6% cannabidiol (CBD), or (4) 12% THC. The subjects who receive 2% THC will serve as the low-dose/active placebo group; while an ideal placebo would not contain any potentially therapeutic action, previous research has shown completely inactive marijuana is rarely effective at producing an effective double-blind. Marijuana will be self-administered daily on an outpatient basis for four weeks, followed by two weeks of none. Within each treatment group, five of 10 subjects will smoke marijuana cigarettes; the other five are assigned to use a vaporizer.

In this groundbreaking study, marijuana will be used as a pharmacological medicine without associated psychotherapy. The primary outcome variable measuring the severity of PTSD will be the Clinician Administered PTSD Scale (CAPS), required by FDA and the European Medicines Agency (EMEA).

At present, the NIDA does not produce any marijuana with significant levels of CBD. We are specifically requesting NIDA produce such a strain for this study. NIDA has previously indicated that it could provide any marijuana strains requested by researchers. Should NIDA be unable to provide marijuana with CBD—due to NIDA’s monopoly on the supply of marijuana for FDA-regulated research—we would have no other sources of supply and we would be forced to eliminate the 6% THC/6% CBD group from the protocol.