Federally Approved Medical Marijuana Study Seeking Arizona Veterans
By Kaila White, AZCentral.com
Within a month or two, Arizona researchers will accept applications for a small number of veterans who have post-traumatic stress disorder to participate in a study in north Phoenix on medical marijuana’s effects on the disorder.
The study is federally approved by the Food and Drug Administration and licensed by the Drug Enforcement Administration. It will study 38 veterans in Phoenix and another 38 at Johns Hopkins University in Baltimore.
It is the first time the DEA and FDA have approved randomized, controlled research intended to develop the actual plant, not oils or synthetics, into a prescription drug to treat PTSD.
If the study shows marijuana is a successful treatment, the ultimate goal is to get FDA approval for marijuana plants to be prescribed to anyone with PTSD, said Brad Burge, director of communications for study sponsor Multidisciplinary Association for Psychedelic Studies.
Among veterans, 30 percent from the Vietnam War have or had PTSD in their lifetimes; 12 percent from the Gulf War have it in a given year; and between 11 and 20 percent from the Iraq and Afghanistan wars have it, according to estimates from the U.S. Department of Veterans Affairs.
The study was first approved in 2014 but stalled after the University of Arizona fired Dr. Sue Sisley, the primary researcher. She believes she was let go for political reasons after she clashed with state lawmakers over medical-marijuana research.
She is now a principal investigator for this study and will be treating all Phoenix patients.
When she left UA, many veterans worried that she would take the study to Colorado, since it was the Colorado Department of Public Health and Environment that granted $2.156 million to MAPS for the study.
“It’s been such a long struggle for these vets. They’ve been standing with us, shoulder to shoulder, all these years,” she said. “We would never turn our backs on these guys. We were determined to keep it here and we found a way to do that.”
How veterans will be selected
The study is seeking veterans who have chronic, treatment-resistant PTSD, meaning they have tried medication or psychotherapy at some point and not responded to it. Applicants should be healthy and without disabling medical problems, Sisley said.
They must be able to visit Deer Valley once or more per week for 12 weeks. If veterans want to relocate from out of state for 12 weeks, that should be fine, she said. She said she is not yet authorized to disclose the exact location.
All veterans will be enrolled and participate in staggered groups within two years of the start date. They will receive compensation, but she is not approved to say how much.
Veterans interested in applying should email firstname.lastname@example.org.
The approval requires that researchers buy marijuana for the study from the National Institute of Drug Abuse. Purchasing has been a long process, but once they receive the drug they can begin screening and enrolling veterans for the study.
How the study will be conducted
Once veterans are enrolled, researchers will teach them how to smoke using the Fulton Puff Procedure, a common method that consists of a long inhale and holding it in before exhaling.
They will have to smoke twice under observation at the lab, to make sure they don’t have any adverse reactions, and then be sent home with a pipe and enough marijuana to last a week.
Once home, veterans have up to 1.8 grams, or about two joints, per day to smoke whenever they want. They must journal about their experience, wear a watch to monitor the quality of their sleep, and return to the lab once a week.
They will smoke one variety of marijuana for three weeks, then be cut off for two weeks to see if they have symptoms of withdrawal or relapse. Then they will repeat the process once more with a different kind of marijuana.
The total process lasts 12 weeks, with six months of follow-up through phone calls or meetings.
What kind they will smoke
Veterans will be randomly assigned to try two of four kinds of marijuana: one with high tetrahydrocannabinol (THC), one with high cannabidiol (CBD), one with an equal ratio of the two, and one placebo.
The types have nothing to do with indica or sativa, the two most common marijuana strains. It’s a popular distinction among marijuana users.
“A lot of people still use that nomenclature, but we try to avoid it. I think the movement in general is trying to move away from it because it’s not really a scientific way of describing a clinical experience,” Sisley said.
The main complaint from veterans interested in the study is that NIDA’s marijuana is low in both THC and CBD compared with what is available at dispensaries across the country, Sisley said. NIDA defines high THC or CBD is above 10 percent, but many dispensaries offer strains above 20 or 30 percent.
“A lot of veterans are arguing this study is sabotaged from the beginning because we’re not letting them access cannabis they normally would,” she said. It is the only legal option available for now.
Sisley said she knows many veterans, firefighters and police officers who use marijuana successfully to manage a variety of medical conditions, but this study will help collect objective data on whether it actually works.
“Right now, all we have is a mountain of anecdotal evidence, but until it’s put through the rigors of a randomized, controlled trial, then I can’t make any judgment on it,” she said.