operation overmed veterans medical marijuana
Medical Marijuana Policy

DEA Approves First-Ever Trial Of Medical Marijuana For PTSD In Veterans

operation overmed veterans medical marijuana
(image via operation overmed)

The U.S. Drug Enforcement Administration (DEA) has formally approved the first-ever randomized controlled trial of whole plant medical marijuana (cannabis) as a treatment for posttraumatic stress disorder (PTSD) in U.S. veterans. 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).

The randomized, blinded, placebo-controlled study will test the safety and efficacy of botanical marijuana in 76 U.S. military veterans with treatment-resistant PTSD. The study is funded by a $2.156 million grant from the Colorado Department of Public Health and Environment (CDPHE) to the California-based non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the research.

The trial will gather safety and efficacy data on four potencies of smoked marijuana with varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD). By exploring the effectiveness of a variety of marijuana strains, the study seeks to generate naturalistic data comparable to how many veterans in medical marijuana states currently use marijuana. Results will provide vital information on marijuana dosing, composition, side effects, and areas of benefit to clinicians and legislators considering marijuana as a treatment for PTSD.

“We have been working towards approval since we opened the Investigational New Drug Application (IND) with the FDA in 2010,” says Amy Emerson, Executive Director and Director of Clinical Research for the MAPS Public Benefit Corporation. “We are thrilled to see this study overcome the hurdles of approval so we can begin gathering the data. This study is a critical step in moving our botanical drug development program forward at the federal level to gather information on the dosing, risks, and benefits of smoked marijuana for PTSD symptoms.”

Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania’s Perelman School of Medicine, will oversee the two separate sites as Coordinating Principal Investigator (PI). Half of the subjects will be treated by Co-Investigator/Site PI Sue Sisley, M.D., in Phoenix, AZ, and the other half by Co-Investigator/Site PI Ryan Vandrey, Ph.D., at Johns Hopkins University in Baltimore, MD. Co-Investigator Paula Riggs, M.D., of the University of Colorado School of Medicine, will oversee the scientific integrity of the study. Blood analysis will be conducted at the University of Colorado, Boulder. MAPS will work with the FDA to manage and monitor data, oversee drug accountability, and ensure that the study follows Good Clinical Practice guidelines.

Since its founding in 1986, MAPS has raised over $36 million for psychedelic therapy and medical marijuana research and education. MAPS is working to evaluate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses approved by the FDA.

Source: MAPSmake a donation

  • skoallio

    There is no scientific evidence that marijuana does anything to treat PTSD. According to the National Center for PTSD. If any organization was to endorse marijuana for PTSD, it would be them. Theyre saying the exact opposite.
    http://www.ptsd.va.gov/professional/co-occurring/marijuana_use_ptsd_veterans.asp

    • wowFAD

      So an organization with “.gov” in their URL — meaning it’s a federal website — wishes to maintain the illusion that cannabis has no medical value. That’s not a surprise. The fact that your image has no cited evidence is also no surprise. Here are a few articles from legitimate scientists.

      Neumeister, A. (2013), THE ENDOCANNABINOID SYSTEM PROVIDES AN AVENUE FOR
      EVIDENCE-BASED TREATMENT DEVELOPMENT FOR PTSD. Depress. Anxiety,
      30: 93–96. doi: 10.1002/da.22031

      D. Mark Anderson, Daniel I. Rees, and Joseph J. Sabia. Medical Marijuana
      Laws and Suicides by Gender and Age. American Journal of Public Health:
      December 2014, Vol. 104, No. 12, pp. 2369-2376.

      Chhatwal, Jasmeer P., et al. “Enhancing cannabinoid neurotransmission augments the extinction of conditioned fear.” Neuropsychopharmacology 30.3 (2005): 516-524.

      See? Citations for articles published by scientists, not federal propaganda.

    • James Peters

      There have been some small studies in the past (PubMed 25467221, 19228182, 26195653).

    • Of course there is no scientific evidence. That is why the study is being done.

  • wowFAD

    In the years directly following the end of the Iraq War (and while Afghanistan was still winding down), the combat-death to suicide ratio for veterans was 1:21 — in simple English, for every one soldier who was killed in action, 21 more would come home and kill themselves. The suicide rate for veterans was so bad that veterans groups would send petitions with thousands of signatures to the White House annually, only to be ignored or placated by a letter from the Drug Czar.

    Research conducted by Anderson and Rees (D. Mark Anderson, Daniel I. Rees, and Joseph J. Sabia. Medical Marijuana Laws and Suicides by Gender and Age. American Journal of Public Health: December 2014, Vol. 104, No. 12, pp. 2369-2376.) concluded that suicide rates in states where medical cannabis is legal are reduced by 9.4% in men ages 30-39 and 10.8% in men ages 20-29. Those are reductions far too significant to overlook, especially given the CDC report showing that suicide rates have been steadily increasing since 1999.

    Some may remember a proposed diet drug called Rimonabant that was a cannabinoid receptor antagonist — a drug that blocks the activation of cannabinoid receptors in the brain. The creators of the drug believed blocking these receptors would reduce appetite, given that cannabis use typically promotes appetite (the munchies). Whether or not Rimonabant worked as an appetite suppressant is unknown as the clinical trials had to be halted. Apparently, blocking the activation of cannabinoid receptors causes severe clinical depression and instigated suicidal thoughts in the trial subjects — loss of hope for the future, feelings of worthlessness, severe loneliness and apathy. Four of the trial’s subjects successfully committed suicide.

    This PTSD research means a lot to our suffering war veterans. Really, it means a lot to the treatment of mental illness, generally. For decades, cannabis opponents have attempted to conflate cannabis use as a *cause* of mental illness, opting to ignore the simpler, correct explanation: self-medication. For too long, the mentally ill have been unfairly labeled as “addicts” while cannabis has been wrongly mischaracterized as the cause of their problems for political reasons. The injustice of funneling the mentally ill into the criminal justice system — just because they used cannabis — is a travesty that has gone on long enough and must end.

    • Fungi Sclerotia 1427

      Ah, Rimonabant…
      I’d LOVE to compulsorily-administrate that to EVERY
      cannabis opponent and “drug warrior” in existence!!! }]:-)>

  • DukyDavyDook797883

    Lets see what the National Center for PTSD has to say about medical marijuana. If any organization were to endorse its use for this disease, it should be them.
    http://www.ptsd.va.gov/professional/co-occurring/marijuana_use_ptsd_veterans.asp

  • SilentPatriot

    Icicles in Hades! =P

  • skoallio

    If medical marijuana helps, I dont know why the biggest PTSD advocacy group keeps saying otherwise.
    ptsd.va.gov/professional/co-occurring/marijuana_use_ptsd_veterans.asp

  • NickyChuck

    Hooray for veterans, and for MAPS! They’re highly respected and known for conducting groundbreaking research on the medical uses of LSD, psilocybin, MDMA, and other so-called narcotics. Support them if you’re looking for a good cause.

  • Robert Dewayne King

    And if the study comes to the conclusion that the condition is best treated with cannabis will they finally remove it from “class 1” ? Or will they still try to claim that it aint medicine ?!

    • saynotohypocrisy

      I have the feeling it’s going to be changed to Schedule II soon, the claim that cannabis has no medicinal use has been smashed into little pieces by now, even prohibs know it’s baloney. But that’s too little too late to be at all satisfactory. That still means cannabis is considered to have a high potential for abuse, while killers alcohol and tobacco aren’t even anywhere on the schedule.

  • Sharon Taulbee

    I wonder what they will use as the placebo….after all, marijuana has an unmistakable smell and taste…Looks like this is part of the DEA’s tactical response regarding demands to either reschedule or completely reschedule marijuana. Regardless, it is high time the door to medical research is opened.

    • NickyChuck

      They’ll use hemp, basically. In other placebo-controlled medical cannabis trials, like one I read for Crohn’s disease, they just use marijuana which has had its psychoactive components bred out.

      • Marine223

        May as well smoke Corn Silk! Do they really think the Vets won’t know they didn’t get buzzed?

  • Sharon Taulbee

    Thank you…well….well now, tricky little bastereds. Good for them. Let the testing process begin. I wonder what reaction the anti-legalization folks will have when marijuana is scientifically proven to kill cancer. As well as being an effective treatment for various other illnesses including PTSD.
    However, what really scares me is what big pharmaceuticals will do with it in order to make their money…..they’ll ruin it by adding poison to it and call it breakthrough medicine….

  • Dominick Carnevale

    This is ridiculous! Politicians and the DEA deciding if we can have medicine. If the pharmaceutical industry introduced a new medicine to cure even a hangnail, it would be approved without the intervention of any politicians.

  • Closet Warrior

    That’s good but while all participants await rigorous vetting for the trials many PTSD vets will commit suicide to kill the demons in their heads!!! Simply NOT acceptable!!!!!

    • saynotohypocrisy

      It’s inhuman to treat anyone this way. And to do it to veterans – they glorify vets with cheap wrap in the flag rhetoric, but when it really matters the prohibs have been stabbing vets in the back.
      The studies will be much better late than never, but if they had any respect for the vast numbers of testimonies available from vets about how cannabis has helped them, they wouldn’t wait another second before allowing vets, in consultation with a doctor, to use medicinal cannabis.
      Cuomo Wasserman-Schultz Biden Kasich Scott Abbott Krispie Kreme. Barbarians all, and maybe sadists.

  • Ken Mohler

    Marijuana stopped my nightmares & relieved my depression…I am a Vietnam , Combat Wounded Veteran , the VA pumped me full of Sleeping meds and anti depressants and even Ritalin and all I got was 40 years of mental misery. I spent months on booze benders and detox and back and forth on different meds , couldn`t hold a job , lost marriages , family , and friends…finally I got off all meds , stopped all alcohol use and smoke a joint in the evening and sleep dream free , I think more than anything it was the sleep I lost kept my brain from fully resting and I was just exhausted from the mental work in dealing with what ever PTSD is . I still have memories and times that I am reminded of the horror but somehow I am able to handle it without medicating with alcohol or prescription alternatives like opioids or speed …I truly know for a fact that marijuana has saved my mind from symptoms that 40 years of medicines best known cures could not … The less time I spend with people the better I enjoy my life , I`ll settle for that , at 71 years old I don`t need a lot of people around me anyway …