Summary: 5280 Magazine reports on the Drug Enforcement Administration (DEA)’s recent approval of MAPS’ clinical trial of medical marijuana for U.S. military veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD). “Ultimately, we want to see the FDA approve marijuana as a legal prescription drug,” explains MAPS Director of Communications and Marketing Brad Burge.
Originally appearing here.
Almost six years after first applying to study whether medical marijuana can help treat Post-Traumatic Stress Disorder (PTSD), a group of researchers has finally won federal approval to begin testing.
On April 19, the Drug Enforcement Agency (DEA) formally approved the clinical study, which is funded by a $2 million grant from the Colorado Department of Public Health and Environment (CDPHE) and conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS), a California-based nonprofit that’s been examining potential therapeutic uses for marijuana and other drugs since 1986. Fittingly, the contract with the state was signed on April 20.
The study will track 76 military veterans who have been diagnosed with PTSD. Using four different potencies of the plant plus a placebo, researchers will attempt to gather qualitative data on the efficacy of each level’s impact on PTSD symptoms via the Clinically Administered PTSD Scale (CAPS), the standard survey-form evaluation used to assess symptoms outlined in the Diagnostic and Statistic Manual of Mental Disorders (DSM-5). Researchers will also monitor the participants’ natural behavior (not directed or manipulated) by observing how much marijuana the veterans smoke (there is a camera on the box of pre-rolled joints they get).
Based on these results, the researchers will make recommendations on marijuana’s effectiveness to treat PTSD symptoms. The veterans will actually receive the treatment at medical centers in Arizona and Maryland. Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania will oversee the study, which has no announced timetable.
The study is trailblazing in its content—it’s the first triple-blind, placebo-controlled study on the safety and efficacy of smoked marijuana to treat symptoms of chronic, treatment-resistant PTSD—but equally significant is the policy precedent it sets. Its approval is a major victory for advocates who want to better understand the plant’s medicinal properties.
“Ultimately, we want to see the FDA approve marijuana as a legal prescription drug,” says Brad Burge, MAPS director of marketing and communications.
For that to happen, the FDA would have to approve marijuana for a specific indication, based on scientific proof that botanical marijuana is safe for human consumption and that it does, in fact, yield medical benefits. If this study is successful, Burge hopes more research will follow to determine which strains are most useful to address certain symptoms, what dosages are appropriate, and best methods of delivery.
Obtaining federal approval for this research was no small task. For the PTSD study, Burge says MAPS spent years securing approvals from the FDA, DEA, an ethics board, the Public Health Service (an approval requirement since done away with by the Obama administration), plus an additional application to purchase the study’s marijuana from the National Institute on Drug Abuse (NIDA)—the only farm from which it can be legally purchased.
As we’ve recounted before, marijuana’s status as a Schedule 1 drug has neutered extensive investigations into the plant’s potential medicinal benefits, primarily because would-be researchers feared the consequences of breaking federal law. But the state-by-state legalization movement that began in Colorado and Washington has blossomed enough that it’s beginning to soften anti-weed attitudes in Washington, DC.
In fact, the DEA announced in early April that it would reach a decision mid-year about whether marijuana should be rescheduled to Schedule II, which means it’s considered to have a high potential for abuse, but some medicinal benefits. Still, FDA approval does not hinge on DEA rescheduling. Burge expects the process to be the reverse of that. Should the FDA find cannabis to be medically useful, the DEA, he suspects, would reschedule it.
Colorado medical cardholders had a hand in making this study possible. While waiting for NIDA’s approval in 2014, MAPS submitted an application to the CDPHE for a grant to fund this study. Flush with cash from application fees for medical marijuana cards, the state established the Medical Marijuana Scientific Advisory Council (MMSAC) in May 2014, to oversee the distribution of $9 million in medical marijuana research grants. By February 2015, nine proposals were chosen. Given the two study locations and relatively large pool of subjects, the MAPS’ study was awarded the most sizable grant, but the organization still needed the DEA’s blessing to claim the funds.
Although there have been some anecdotal indications that marijuana is an effective treatment for PTSD, that hasn’t been scientifically verified. The best news about this study is that it’s hopefully the first of many that will can determine how powerful a medicine weed is—or isn’t.