The study will be conducted by the California-based Multidisciplinary Association for Psychedelic Studies (MAPS) with embattled Arizona Dr. Sue Sisley, fired from the University of Arizona in 2014 after complaints about her cannabis-related work by a conservative Republican lawmaker.
Sisley and MAPS have been trying to get the study underway for about seven years, facing numerous challenges including where the study would be carried out and when the DEA would allow it to obtain legally the marijuana to be used. Both of the goals now have been met, and the study may begin as soon as June in the Arizona and Colorado testing sites, MAPS spokesman Brad Burge says.
The DEA approval, which came earlier this week, "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," according to MAPS.
It's been an exciting week for the long-anticipated MAPS study: On Wednesday, MAPS signed a contract with the Colorado Department of Public Health and Environment, which is cutting a check for $2.156 million to fund the study. If you didn't already know, Wednesday was the unofficial pot-appreciation day, 4/20.
"We were impressed the state of Colorado has a sense of humor," Sisley says.
Arizona could have funded the study with the millions of dollars in patient and dispensary fees sitting in the state's medical-marijuana fund, but Arizona's conservative leaders would rather score political points with an anti-cannabis stance than help veterans.
As New Times' in-depth article on Sisley explained in 2014, former state Representative Ethan Orr (R-Tucson) floated a bill in 2014 that would have allowed the fund to be used for primary research into medical marijuana of exactly the type MAPS wanted to do. State Senator Kimberly Yee (R-Phoenix) refused to let the bill be heard in a committee she chaired, invoking the wrath of veterans who began working on a futile campaign to recall Yee.
Another powerful state senator, Andy Biggs of Gilbert, struck back at the veterans with a bill amendment that would have made it illegal for state money to go toward marijuana research. Biggs reportedly complained directly to the legislative liaison for the University of Arizona, where Sisley had a contract to work on telemedicine and act as coordinator for a physician-education program on medical marijuana.
Sisley was "lobbying too aggressively and inappropriately," Biggs told the liaison that April. Within days, the university recruited and hired another doctor to replace Sisley in the telemedicine department. She was booted from her U of A office a few months later.
But MAPS and Sisley didn't give up. They continued submitting paperwork to the DEA, hunted for appropriate space to conduct the trials, and lobbied the state of Colorado — successfully — to pay the bills. In the meantime, the Arizona Department of Health Services under former Director Will Humble added PTSD as a qualifying condition for the state's medical-marijuana program.
The biggest obstacle to launching the study was getting the DEA to agree to allow federally grown marijuana to be used for the study. A small farm at the University of Mississippi is the only place where federally legal marijuana is grown, under the oversight of the National Institute on Drug Abuse. But now that the final hurdle's been cleared by the DEA, the Mississippi cannabis is expected to be on its way in a few more weeks.
Sisley will be a co-investigator and "site principal investigator" for the Phoenix trials. Thirty-eight vets will undergo the tests in a north Phoenix warehouse that MAPS still is in the process of furnishing. Another 38 will participate in the other half of the study at Johns Hopkins University in Baltimore under the supervision of co-investigator/site P.I. Ryan Vandrey. Marcel Bonn-Miller of the University of Pennsylvania's Perelman School of Medicine will oversee operations as principal investigator of the study, and Dr. Paula Riggs of the University of Colorado School of Medicine will oversee the scientific integrity of the study.
Sisley says more than 76 total veterans will likely be recruited, since some people inevitably will drop out. She said she's unable per DEA rules to release the address of the Phoenix trial site.
The researchers will use a randomized, blinded, placebo-controlled study method utilizing four different potencies of the Mississippi marijuana.
No veterans have yet been selected for the trials, but Sisley says she's received phone calls and e-mails from hundreds of people interested in participating.
Veterans who believe they may qualify for the program and want to participate should e-mail [email protected]