By DAN FROSCH
Published: July 18, 2011
DENVER â€” For years now, some veterans groups and marijuana advocates have argued that the therapeutic benefits of the drug can help soothe the psychological wounds of battle. But with only anecdotal evidence as support, their claims have yet to gain widespread acceptance in medical circles.
Now, however, researchers are seeking federal approval for what is believed to be the first study to examine the effects of marijuana on veterans with chronic post-traumatic stress disorder.
The proposal, from the Multidisciplinary Association for Psychedelic Studies in Santa Cruz, Calif., and a researcher at the University of Arizona College of Medicine, would look at the potential benefits of cannabis by examining 50 combat veterans who suffer from the condition and have not responded to other treatment.
â€śWith so many veterans from the wars in Iraq and Afghanistan, there is a widely accepted need for a new treatment of PTSD,â€ť said Rick Doblin, founder and executive director of the psychedelic studies group. â€śThese are people whom we put in harmâ€™s way, and we have a moral obligation to help them.â€ť
In April, the Food and Drug Administration said it was satisfied that safety concerns over the study had been addressed by Mr. Doblin and Dr. Sue Sisley, an assistant professor of psychiatry and internal medicine at Arizona, according to a letter from the drug administration provided by Mr. Doblin.
But the letter also noted that the project could not go forward until the researchers identified where they would get their marijuana. And that cannot happen, Mr. Doblin said, until the project is approved by a scientific review panel from the Department of Health and Human Services, which includes representatives from an assortment of federal health agencies.
If the proposal is approved, Mr. Doblin said, the researchers will use marijuana grown by the University of Mississippi under a contract with the National Institute on Drug Abuse. It is the only marijuana permitted to be used in federally approved studies.
A Health and Human Services spokeswoman said the proposal was still under review. â€śThe production and distribution of marijuana for clinical research is carefully restricted under a number of federal laws and international commitments,â€ť the spokeswoman, Tara Broido, said in an e-mail. â€śStudy proposals are reviewed for scientific quality and the likelihood that they will yield data on meaningful benefits.â€ť
An institutional review board must also approve the study, as well as the Drug Enforcement Administration, Mr. Doblin said.
Getting final approval from the federal government could prove difficult, Mr. Doblin and Dr. Sisley conceded. They said it was far more challenging to get authorization for a study that examines the benefits of an illegal drug than its risks.
â€śWe really believe science should supersede politics,â€ť Dr. Sisley said. â€śThis illness needs to be treated in a multidisciplinary way. Drugs like Zoloft and Paxil have proven entirely inadequate. And thereâ€™s anecdotal evidence from vets that cannabis can provide systematic relief.â€ť
Medical marijuana is legal in 16 states and the District of Columbia. But only New Mexico and Delaware specifically list post-traumatic stress disorder as a qualifying condition for treatment, according to the Marijuana Policy Project, a Washington-based group that supports legal regulation of the drug.
Currently, nearly a third of the 4,982 patients approved for medical marijuana in New Mexico suffer from post-traumatic stress disorder, more than any other condition, according to the stateâ€™s health department. It is unclear how many are veterans.
One recent Army veteran from Texas who fought in Iraq for 18 months beginning in 2006, said he used marijuana three times a day in lieu of the painkillers and antidepressants he was prescribed after returning home. He asked that his name not be used because Texas does not allow medical marijuana.
The veteran, who said he had been shot in the leg and suffered numerous head injuries from explosions while deployed as a Humvee gunner, said marijuana helped quiet his physical and psychological pain, while not causing the weight loss and sleep deprivation brought on by his prescription medications.
â€śI have seen it with my own eyes,â€ť he said. â€śIt works for a lot of the guys coming home.â€ť
If the study is approved, veterans who participate would be observed on an outpatient basis over three months, Mr. Doblin said. During two four-week increments, they would be given up to 1.8 grams of marijuana a day to treat anxiety, depression, nightmares and other symptoms brought on by PTSD. Researchers would also observe the veterans for periods when they are not permitted to use marijuana.
In addition to a placebo, researchers plan to use four marijuana strains in the study, each containing different levels of tetrahydrocannabinol (THC), a primary component of the drug. One of the strains will also contain cannabidiol (CBD), another ingredient thought to have an anti-anxiety effect.
Mr. Doblin said the veterans would be allowed to use the marijuana at their own discretion. Half will be instructed to smoke the drug, while the other half will inhale it through a vaporizer.