Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 76 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Co-Investigators and Site Principal Investigators: Sue Sisley, M.D., and Ryan Vandrey, Ph.D.
Coordinating Principal Investigator: Marcel Bonn-Miller, Ph.D.
Co-Investigator: Paula Riggs, M.D.
This study will explore whether smoking or vaporizing marijuana can help reduce PTSD symptoms in 76 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD). Participants must 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.
$2,156,000 estimated study budget • $2,156,000 grant awarded by the State of Colorado
On November 11, 2009, Dr. Sue Sisley and Rick Doblin first begin discussing marijuana/PTSD study.
On November 17, 2010, MAPS received an Investigational New Drug identification number for marijuana from the FDA.
On December 15, 2010, the FDA placed the study on full clinical hold.
On January 24, 2011, NIDA informs MAPS that it could provide the requested marijuana.
On February 3, 2011, the FDA sent MAPS a letter outlining several issues relating to protocol design.
On February 9, 2011, the FDA and MAPS held a teleconference during which MAPS successfully addressed the FDA’s concerns, including the potential for diversion of marijuana used in the study.
On March 15, 2011, MAPS submitted the revised protocol incorporating the changes discussed on February 9 to the FDA.
On April 28, 2011, the revised protocol 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 August 16, 2011, after a 4½ month wait, HHS informs MAPS that the NIDA/PHS reviewers unanimously rejected the protocol.
On October 25, 2012, the University of Arizona Institutional Review Board (IRB) approved the study protocol.
On October 24, 2013, MAPS resubmitted the study protocol (cover letter) to HHS.
On March 12, 2014, after 4½ months, HHS approved the study protocol (cover letter).
On April 17, 2014, NIDA informs MAPS that, despite what it said on 1/24/2011, it does not have the marijuana required for our study but will need to grow a new crop.
On June 27, 2014, Dr. Sue Sisley was fired by the University of Arizona for political reasons.
On August 18, 2014, MAPS requests that NIDA grow four different strains of research marijuana for the study.
On December 17, 2014, the Colorado Department of Public Health and Environment awarded a $2.156 million grant to MAPS for the study.
On March 11, 2015, the IRB at the University of Pennsylvania approved the study protocol.
On March 24, 2015, the IRB approves the protocol for Dr. Sue Sisley’s new study location in Phoenix, Arizona.
On April 24, 2015, NIDA informs MAPS that three of the four strains requested six months previously are available (placebo; 12% THC <1% CBD; 12% CBD<1% THC). For the fourth, NIDA could provide 9%THC/9%CBD, somewhat close to the 12% THC/12% CBD we requested, or we could wait another growing cycle. MAPS accepts the 9%THC&9%CBD for this Phase 2 study. NIDA marijuana is adequate for Phase 2 but not Phase 3. NIDA is authorized to grow only for research, not prescription sales, and FDA requires Phase 3 to be conducted with the same drug proposed to be marketed.
On June 22, 2015, the U.S. Department of Health and Human Services (HHS) announced that it had eliminated the redundant Public Health Service (PHS) review process for federally regulated marijuana research, removing a significant barrier to privately funded medical marijuana research.
On September 22, 2015, the IRB at Johns Hopkins University provisionally approved the study protocol pending DEA approval.