Last week, fired UA researcher Sue Sisley learned that the Colorado Department of Public Health and Environment awarded the psychiatrist $2 million to her sponsor, the Multidisciplinary Association for Psychedelic Studies (MAPS), for their marijuana study for symptoms of post-traumatic stress disorder in 76 U.S. veterans.
According to MAPS, Colorado's Medical Marijuana Scientific Advisory Council recommended that MAPS receive the grant in late November. The state's decision followed the Council's recommendation, giving MAPS the largest of eight grants awarded by CDPHE. All of the other grantees are major research universities.
"As the very first public funding that MAPS has ever received in our 28-and-half-year history, the award clearly shows that attitudes are improving about research into the therapeutic benefits of Schedule I drugs," said Rick Doblin, 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 Sisley, 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 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 Sisley's portion of the study after she was fired in June for political reasons by the UA. 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 Sue Sisley, and the other half by principal investigator Ryan Vandrey at Johns Hopkins University in Maryland. Marcel Bonn-Miller of the University of Pennsylvania's Perelman School of Medicine, will oversee the two separate sites as coordinating investigator. Co-investigator Paula Riggs, 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.