Summary: Psychiatry Advisor publishes an article by Dr. Sue Sisley’s about MAPS’ upcoming study of medical marijuana for 76 U.S. military veterans with post-traumatic stress disorder (PTSD). Sisley highlights the hurdles that she and MAPS have overcome to gain approval for their current medical marijuana research with the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA). “Our research is intended to address some of the unanswered questions surrounding medical marijuana, particularly the proper dosage and cannabinoid ratio for PTSD patients,” writes Sisley.
Originally appearing here.
The use of medical marijuana to treat patients with treatment-resistant, post-traumatic stress disorder (PTSD) is supported by a number of sources, including research in lab animals, functional MRI imaging in humans, and anecdotal reports from countless health practitioners and patients. Additionally, clinical research in Israel1 evaluating medical marijuana as treatment for PTSD has been promising.
I will also be conducting my own study of cannabis in PTSD in the hopes of helping to get this valuable therapy available those who need it. It will test four strains of smoked marijuana, each containing different concentrations of tetrahydrocannbinol (THC) and cannabidiol (CBD), two compounds in marijuana with therapeutic effects, in two three-week stages, as a pharmacological agent to manage PTSD symptoms in 76 U.S. military veterans.
The primary measured outcome will be the Clinician Administered PTSD Scale (CAPS-5), alongside extensive secondary outcomes including sleep patterns, depression, withdrawal symptoms, metabolic and inflammation panels, and self-reporting by the patients.
The study is a collaboration between the Multidisciplinary Association for Psychedelic Studies (MAPS), me, and researchers at Johns Hopkins University, the University of Colorado, and the University of Pennsylvania.
One reason to be confident that marijuana is an effective PTSD treatment are the results of New Mexico psychiatrist George Greer’s 2014 study, published in the Journal of Psychoactive Drugs.2
Greer collected data from 80 military veterans who met DSM-V criteria for PTSD, including the symptoms of re-experiencing, avoidance, and hyperarousal. Measured using the CAPS-5, the results indicated an average 75% reduction in all three areas of PTSD symptoms while using cannabis.
However, medical marijuana is hampered by current U.S. federal policies obstructing Food and Drug Administration (FDA)-approved research. This includes a redundant multi-agency review process that creates unnecessary red tape and wasteful government spending.
Like other drugs, cannabis should undergo a rigorous FDA-approval process. But unlike studies of other Schedule I drugs, only cannabis research must pass an additional review process called the Public Health Service (PHS) Protocol Review before the National Institute on Drug Abuse (NIDA) will release the research material (marijuana).
NIDA is currently the sole monopoly supplier of cannabis for use in privately funded drug development research.
We are asking for your help in ending two unique barriers to marijuana research: the NIDA monopoly and the PHS review process.
NIDA has a fundamental conflict of interest in deciding which studies it will allow. The agency’s mission statement restricts it from approving research that may help determine the therapeutic potential of marijuana. Thus, scientists hoping to discover relevant information about medical marijuana dosing, administration mechanisms, and other clinical practicalities are prevented from obtaining research material.
Even researchers who do manage to obtain approval to purchase NIDA marijuana have had to contend with cannabis that is inferior or of lower potency than that which is readily available in state-regulated dispensaries.
For any FDA-regulated drug development study (including MAPS’ currently ongoing series of MDMA-assisted psychotherapy for PTSD studies), researchers must obtain approval from the FDA, an Institutional Review Board, and, for Schedule I drugs, the Drug Enforcement Administration.
For marijuana, however, due to a 1999 guidance set forth by the U.S. Department of Health and Human Services, there is an additional, redundant hurdle. This hurdle has delayed our study over four years, and ensures that marijuana is more difficult to study than any other Schedule I substance, ranging from LSD to heroin. During the years our study was prevented from happening, over 25,000 U.S. veterans committed suicide.
Medical marijuana researchers are now seeking to use state funds collected from dispensary and patient application fees to fund peer-reviewed medical marijuana drug development research, to enable doctors to make scientifically grounded decisions when treating their patients with cannabis.
For example, the Arizona Department of Health Services currently holds over $6 million in voter-protected medical marijuana surplus funds which could be allocated to rigorous marijuana research.
Our research is intended to address some of the unanswered questions surrounding medical marijuana, particularly the proper dosage and cannabinoid ratio for PTSD patients. To put patients, front and center, rather than politics, there is a desperate need to expand cannabis research. Without this research, we are leaving medical marijuana open for political opportunists, rather than allowing doctors to explore new options that serve the best interests of our patients.