Colorado’s Medical Marijuana Scientific Advisory Council recommended that MAPS receive the grant on November 24. Yesterday’s decision followed the Council’s recommendation, giving MAPS the largest of eight grants awarded by CDPHE 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.”
The study will evaluate the safety and effectiveness of smoked marijuana to treat symptoms of PTSD in 76 U.S. veterans, and will be the first randomized controlled trial of whole plant (botanical) marijuana as a treatment for PTSD.
“With this grant, we are one step closer to determining if and how cannabis can mitigate the symptoms of PTSD,” said Sue Sisley, M.D., one of the study’s two Principal Investigators. “Colorado has brought us one step closer to truly helping our vets. I’m grateful to MAPS and everyone who is making this journey with us.”
Despite the award and prior Food and Drug Administration and Public Health Service (PHS) approval, the study still faces significant 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. The U.S. Department of Health and Human Services’ PHS review committee granted MAPS permission to purchase the marijuana from NIDA in March 2014, but NIDA has not yet been able to provide the marijuana required for the study. NIDA is currently the only legal source of marijuana for federally sanctioned research in the U.S.
“To end federal obstruction of medical marijuana drug development research, the NIDA monopoly needs to end, as does the PHS protocol review process for access to NIDA marijuana,” said Doblin.
MAPS will also need new Institutional Review Board (IRB) approval for Dr. Sisley’s portion of the study after she was fired in June for political reasons by the University of Arizona. The study will also require clearance from the U.S. Drug Enforcement Administration once the marijuana has a delivery date, which MAPS does not expect to be a significant hurdle.
Half of the subjects will be treated by Principal Investigator Sue Sisley, M.D., and the other half by Principal Investigator Ryan Vandrey, Ph.D., at Johns Hopkins University in Maryland. Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania’s Perelman School of Medicine, will oversee the two separate sites as Coordinating Investigator. Co-investigator Paula Riggs, M.D., of the University of Colorado School of Medicine, will oversee scientific integrity of the study. Blood analysis will be conducted at the University of Colorado, Boulder. MAPS will work with the FDA, manage and monitor data, maintain drug accountability, and ensure that the study follows Good Clinical Practice guidelines.
Since its founding in 1986, MAPS has disbursed over $20 million for psychedelic therapy and medical marijuana research and education, all donated by individuals and family foundations. MAPS is working to evaluate the safety and efficacy of botanical marijuana as a potential prescription medicine for specific medical uses approved by the FDA.