The U.S. Drug Enforcement Administration (DEA) has formally approved the first-ever randomized controlled trial of whole plant medical marijuana (cannabis). The DEA’s approval marks the first time a clinical trial intended to develop smoked botanical marijuana into a legal prescription drug has received full approval from U.S. regulatory agencies, including the DEA and the Food and Drug Administration (FDA).
I wrote a little thing about the study last year. Read on after the jump.
Ever wonder why there is so much scientific evidence supporting marijuana’s harms, but relatively little about its possible benefits?
Last month I got a peek into the answer (and how the balance is changing) after spending some time with the fine folks at MAPS – the Multidisciplinary Association for Psychedelic Studies – at the annual meeting of the American Psychiatric Association, held this year in Toronto. They had set up their booth in the conference’s exhibition hall, surrounded by slick pharma displays promising the next wave of mental health treatment breakthroughs, to tell a very unique story: that compounds we’ve had around all along might be the answer…..if only we were allowed to study them.
MAPS is a “non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.” Among the projects showcased at the conference exhibit, which included studies of MDMA, ibogaine, and LSD/psilocybin as treatment aids for a number of psychiatric conditions, was a study recently launched in Colorado that will test medical marijuana in the treatment of PTSD (post-traumatic stress disorder – a condition that is not just debilitating to live with, but also contributes to medical problems, disability, drug abuse, and suicide). Despite full funding (to the tune of $2.15 million!) from the Colorado Department of Public Health & Environment, the study has taken years go get underway, thanks to countless hurdles set up by the FDA, the DEA, the National Institute on Drug Abuse, the Public Health Service, and various research review boards overseeing the idea of intentionally giving Schedule I illegal drugs to humans. But now, having cleared the last hurdle, we are on our way to learning about potential clinical benefits of whole-plant, smoked marijuana.
What the study does:
The study will enroll 76 U.S. veterans with chronic, treatment-resistant PTSD (meaning conventional medications/psychotherapy were tried and nothing has worked). These patients will then be given one of 4 varieties of marijuana to smoke: 1. Placebo (no THC/no CBD), 2. high THC/low CBD, 3. high CBD/low THC, and 4. High THC/high CBD. They will get to choose how much or little to smoke (up to a certain limit of course), and PTSD symptoms will be measured to see if they decrease over the course of 8 weeks.
As a side note, I think the THC vs. CBD part of the experiment is an important one, because while we all know THC – the chemical in marijuana that makes you feel high – the lesser-known CBD (cannabidiol) may make all the difference here. CBD is one of the hundreds of other chemical compounds contained in marijuana smoke, and has been said to help treat neuro-inflammation, epilepsy, oxidative injury, vomiting and nausea, anxiety, and schizophrenia. Importantly, according to some, it may specifically counteract the undesirable effects of marijuana that have everyone worried (like cognitive impairment, paranoia, or increased risk of developing psychosis or addiction), so may be a key to reducing any “reefer madness” worries.
Why this is a big deal (IMO):
For one, this is the first study ever to establish a safety and efficacy profile for whole-plant, smoked marijuana in the treatment of psychiatric symptoms. Sure, previous studies have had similar ideas, but have focused on synthetic compounds and extracts, which are bound to miss any synergistic effects among all the compounds available in whole-plant marijuana. It may also improve marijuana’s public reputation by introducing more nuance into the debate: by testing different strains and showing that the psychiatric benefits may be independent from the “high,” we can start moving away from the blanket opinion that all cannabis is bad all the time, and show that smoking it can be more than a nuisance to productive society. And finally, thanks to MAPS’ persistence in challenging and clearing the procedural and political hurdles obstructing this kind of research, it feels like we’re one step closer to fairer and more balanced scientific treatment of marijuana…and as such, to dismantling the failed policies of the war on drugs.