A pair of research projects funded by $20 million in tax revenue from Michigan’s adult-use cannabis program will analyze the effects of medical marijuana in military veterans, state officials announced on Tuesday.
The bulk of the money, nearly $13 million, will examine “the efficacy of marijuana in treating the medical conditions of United States armed service veterans and preventing veteran suicide,” according to recipients at the Multidisciplinary Association for Psychedelic Studies (MAPS). The grant will fund the next step of a study researchers say is the first clinical trial of inhaled botanical marijuana for post-traumatic stress disorder (PTSD) and only the second to compare the safety and efficacy of cannabis against a placebo.
Another $7 million in marijuana revenue-funded grant money was awarded to Wayne State University’s Bureau of Community Action and Economic Opportunity, which has partnered with researchers to study how cannabis might treat a variety of mental health disorders, including PTSD, anxiety, sleep disorders, depression and suicidality. Both new grants come from Michigan’s $20 million Veteran Marijuana Research Grant Program, which was established by the state’s legalization law approved by voters in 2018.
PTSD, depression and substance use disorders are all common among veterans, MAPS says. The disorders are also significant contributors to suicidality.
The tax revenue will fund Phase 2 of the organization’s clinical trial comparing the safety and efficacy of inhaled cannabis against a placebo. The research will also “not exclude” military veterans with major depressive disorder and substance use disorder, MAPS said. A total of 320 veterans across four sites, two of which are in Michigan, will spend five weeks “self-administering inhaled, self-titrated doses of high-quality botanical cannabis on an outpatient basis for treatment of PTSD.”
In other words, veterans will be able to smoke marijuana at home, however they like, for more than a month. Which is precisely what makes it a realistic study.
Berra Yazar-Klosinki, chief scientific officer for MAPS Public Benefit Corporation, said the grant funding provides the resources to “align the body of scientific evidence with cannabis that more closely mirrors what is available within state-regulated cannabis programs.” She added that the group “overcame significant regulatory obstacles obstructing cannabis research to conduct the first clinical trial of inhaled cannabis for PTSD.”
— MI Dept. of Licensing & Regulatory Affairs (@michiganLARA) August 10, 2021
Veterans have been a potent force in the decades-long movement to end America’s war on drugs, playing key roles in uniting disparate political groups to turn the tide on cannabis prohibition and, increasingly, to explore the therapeutic potential of other controlled substances, including MDMA and psychedelics.
But as with much of the medical marijuana movement, support among veterans for the most part didn’t result from clinical studies, which were virtually impossible under widespread prohibition. Instead it came from individual and word-of-mouth experiences among veterans and their communities.
Funded by Michigan’s $20 million Veteran Marijuana Research Grant Program, which was established by 2018 the state’s legalization law, the new study is aimed at determining how effective smoked cannabis actually is at treating PTSD and its symptoms. If it’s demonstrated to work well, that could lead to Phase 3 trials and ultimately raw cannabis being developed and sold as a pharmaceutical. Eventually a joint—or at least one approved by the U.S. Food and Drug Administration (FDA)—could be covered by a veteran’s insurance.
“In Israel and Canada, veterans are able to use a certain amount of cannabis per day and have it reimbursed through their veterans health service programs,” Yazar-Klosinki told Marijuana Moment in an interview, noting that while the United States has made incremental progress toward reform, veterans still face serious obstacles to using cannabis under a doctor’s supervision.
“We still have more regulatory negotiations ahead of us in order to convince the FDA to let us use the kind of cannabis that that veterans are already using in the United States,” she said.
Yazar-Klosinki explained that because of difficulties sourcing high-quality cannabis from the few government-approved growers in the U.S., the team is planning to bring in the cannabis for Phase 2 trials from a regulated grower overseas. The team is “selecting appropriately qualified growers from abroad that have already validated their production and measurements…at the level of good manufacturing practices,” she said.
If the trials are successful, however, MAPS could ultimately develop a cannabis pharmaceutical product through its public benefit corporation, said founder and executive director Rick Doblin.
“Michiganders are granting non-profit researchers the opportunity to establish whether marijuana is helpful for veterans with PTSD,” Doblin said in a statement. “If so, we will seek to return that generosity by developing a public-benefit cannabis pharmaceutical product that would be eligible for insurance coverage, just like any other pharmaceutical drug.”
MAPS previously organized what it says was the only FDA-regulated controlled study of cannabis for PTSD, which was funded with $2.2 million Colorado’s Department of Public Health and Environment. All treatment groups showed “good tolerability and improvements in PTSD symptoms after three weeks,” a MAPS press release says. The study “further informed the development of this second, larger trial, identifying that higher quality cannabis must be used to differentiate between responses of the control group and the placebo group.”
The Wayne State University project, meanwhile, will “explore the biochemical mechanisms through which [cannabis] could be employed to treat PTSD, anxiety, sleep disorders, depression, and suicidality,” according to the research team’s proposal.
Strict regulations over who could legally grow and supply cannabis for research purposes has long limited meaningful experiments into the therapeutic value of cannabis. Sue Sisley, a researcher at the Scottsdale Research Institute, where the earlier MAPS study was conducted, complained in 2017 that cannabis provided for research purposes by the federal government “looked like green talcum powder.”
“It didn’t look like cannabis. It didn’t smell like cannabis,” Sisley said at the time, adding that some samples failed to conform to potency levels needed for the study. Others were so contaminated with mold they would have failed testing requirements in state-regulated markets.
Sisley, one of the authors of Phase 1 of the current study, is among a group of scientists and military veterans currently suing the U.S. Drug Enforcement Administration (DEA) in an effort to force the federal government to formally reconsider marijuana’s federal Schedule I classification, which severely limits research. A panel of the U.S. Court of Appeals for the Ninth Circuit heard arguments in the case in June.
Meanwhile, some in Washington, D.C., are pushing to ease restrictions on research. The congressional infrastructure bill backed by President Joe Biden includes a number of cannabis provisions, including one that would direct the government to create a plan to eventually allow researchers to study cannabis from retailers in legal states. A bipartisan amendment proposed last week would further expand research into marijuana and CBD.
Also last week, the Senate Appropriations Committee approved an amendment meant to promote veterans’ access to medical marijuana by allowing doctors at the U.S. Department of Veterans Affairs (VA) to issue cannabis regulations in legal states.
The federal government has already taken some initial steps to promote research. Most notably, DEA recently notified several companies that it’s moving toward approving their applications to become federally authorized manufacturers of marijuana for research purposes.
In other Michigan cannabis news, state Attorney General Dana Nessel (D) filed a legal brief this week arguing that residents fired from jobs for off-hours cannabis use that doesn’t affect their work performance should still be eligible for unemployment benefits.
Photo courtesy of Mike LatimerWe Are Social