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.
$2,000,000 estimated study budget • $2 million grant awarded by the State of Colorado
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 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 July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon.
On September 16, 2011, HHS informed MAPS that the NIDA/PHS reviewers had unanimously rejected the protocol as currently designed. 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.
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 14, 2014, HHS approved the study protocol (cover letter).
On December 17, 2014, the Colorado Department of Public Health and Environment awarded a $2 million grant to MAPS for the study.