After more than three years of delay, researchers are preparing to launch a landmark clinical trial aimed at evaluating the efficacy of smoking medical marijuana in treating post-traumatic stress disorder (PTSD) in veterans. The funding for this study comes from tax revenue from legal marijuana sales in Michigan.
The Multidisciplinary Association for Psychedelic Drug Research (MAPS) announced this week that the US Food and Drug Administration (FDA) has approved a phase two study, which MAPS described in a press release as a “randomized, placebo-controlled study of 320 retired military personnel who had used marijuana and suffered from moderate to severe post-traumatic stress disorder.
The organization said that this study “aims to investigate the comparison between inhaling high content THC dried Fried Dough Twists and placebo cannabis, and the daily dose is adjusted by the participants themselves.” The study aims to reflect the consumption patterns that have occurred nationwide, and to study “the actual use of inhaling cannabis, to understand its potential benefits and risks in the treatment of post-traumatic stress disorder.”
MAPS stated that the project has been in preparation for many years and pointed out that there were many issues encountered when applying for research approval from the FDA, which were only recently resolved. The organization stated, “After three years of negotiations with the FDA, this decision opens the door to future research on marijuana as a medical option and brings hope to millions of people
The MAPS press release states, “When considering the use of marijuana to treat post-traumatic stress disorder, pain, and other serious health conditions, these data are important for informing patients, healthcare providers, and adult consumers, but regulatory barriers have made meaningful research on the safety and efficacy of marijuana products typically consumed in regulated markets very difficult or unattainable
MAPS stated that over the years, it has responded to five clinical suspension letters from the FDA, which have hindered the progress of research.
According to the organization, “On August 23, 2024, MAPS responded to the FDA’s fifth letter on clinical suspension and submitted a formal dispute resolution request (FDRR) to resolve the persistent scientific and regulatory differences with the department on four key issues”: “1) the proposed THC dosage of medical Fried Dough Twists products, 2) smoking as a way of administration, 3) electronic fumigation as a way of administration, and 4) recruitment of participants who have not tried cannabis treatment.”
The main researcher of the study, psychiatrist Sue Sisley, stated that the trial will help further clarify the scientific legitimacy of using medical marijuana to treat post-traumatic stress disorder. Despite the increasing use of marijuana by post-traumatic stress disorder patients and its inclusion in many states’ medical marijuana programs, she stated that there is currently a lack of rigorous data to evaluate the efficacy of this treatment approach.
Sisley said in a statement: “In the United States, millions of Americans control or treat their symptoms through direct smoking or electronic atomization of medical marijuana. Due to the lack of high-quality data related to cannabis use, most of the information available to patients and regulators comes from the ban, focusing only on potential risks without considering potential treatment benefits.”
In my practice, veteran patients shared how medical marijuana can better help them control post-traumatic stress disorder symptoms than traditional drugs, “she continued. Veterans’ suicide is an urgent public health crisis, but if we invest in researching new therapies for life-threatening health conditions such as post-traumatic stress disorder, this crisis can be resolved
Sisley said that the second phase of clinical research “will generate data that doctors like me can use to develop treatment plans and help patients control symptoms of post-traumatic stress disorder
Allison Coker, the head of cannabis research at MAPS, said that the FDA was able to reach this agreement because the agency stated that it would allow the continued use of commercially available medical cannabis with THC content in the second phase. However, electronic nebulized marijuana remains on hold until the FDA can evaluate the safety of any specific drug delivery device.
In response to the FDA’s separate concerns about recruiting participants who have never been exposed to marijuana treatment to participate in clinical studies, MAPS has updated its protocol to require participants to have “experienced inhaling (smoking or vaping) marijuana.
The FDA also questioned the design of the study that allows for self-adjusting doses – meaning that participants can consume marijuana according to their own wishes, but not beyond a certain amount, and MAPS refused to compromise on this point.
A spokesperson for the FDA told industry media that she was unable to provide detailed information that led to the approval of the phase two trial, but revealed that the agency “recognizes the urgent need for additional treatment options for serious mental illnesses such as post-traumatic stress disorder
The study was funded by the Michigan Veterans Cannabis Research Grants Program, which uses the state’s legal marijuana tax to provide funding for FDA approved non-profit clinical trials to “investigate the efficacy of medical marijuana in treating diseases and preventing veteran self harm in the United States.
State government officials announced $13 million in funding for this study in 2021, which is part of a total of $20 million in grants. That year, another $7 million was allocated to Wayne State University’s Community Action and Economic Opportunity Bureau, which collaborated with researchers to study how medical marijuana can treat various mental health disorders, including post-traumatic stress disorder, anxiety, sleep disorders, depression, and suicidal tendencies.
At the same time, in 2022, the Michigan Cannabis Administration proposed donating $20 million that year to two universities: the University of Michigan and Wayne State University. The former proposed to study the application of CBD in pain management, while the latter received funding for two independent studies: one was the “first randomized, controlled, large-scale clinical trial” aimed at investigating whether the use of cannabinoids could improve the prognosis of post-traumatic stress disorder veterans undergoing long-term exposure (PE) therapy; Another study is the impact of medical marijuana on the neurobiological basis of neuroinflammation and suicidal ideation in veterans with post-traumatic stress disorder.
MAPS founder and president Rick Doblin stated during the organization’s announcement of the recently FDA approved clinical trial that American veterans “urgently need treatment that can alleviate their symptoms of post-traumatic stress disorder (PTSD).
MAPS is proud to lead the way in opening up new research avenues and challenging the traditional thinking of the FDA, “he said. Our medical marijuana research challenges the FDA’s typical methods of administering drugs according to plan and time. MAPS refuses to compromise research designs to conform to FDA’s standard thinking, to ensure that medical marijuana research reflects its real-life use
MAPS’s past research not only included marijuana, but also, as the organization’s name suggests, psychedelic drugs. MAPS has created a spin off drug development company, Lykos Therapeutics (formerly known as MAPS Philanthropy), which also applied to the FDA earlier this year for approval to use methamphetamine (MDMA) to treat post-traumatic stress disorder.
But in August, the FDA refused to approve MDMA as an adjuvant therapy. Another study published in the Journal of Psychiatric Research found that although clinical trial results are “encouraging,” further research is needed before MDMA assisted therapy (MDMA-AT) can replace currently available forms of treatment.
Some health officials subsequently stated that despite this, this effort still reflects progress at the federal government level. Leith J. States, Chief Medical Officer of the Office of the Assistant Secretary of Health in the United States, said, “This indicates that we are moving forward, and we are doing things in a gradual manner
In addition, this month, the hearing judge of the US Drug Enforcement Administration (DEA) rejected the request of the Veterans Action Committee (VAC) to participate in the upcoming hearing on the Biden administration’s marijuana reclassification proposal. VAC stated that the proposal is a “mockery of justice” as it excludes key voices that may be affected by policy changes.
Although DEA has introduced a relatively inclusive stakeholder portfolio witness list, VAC stated that it has still “failed” to fulfill its duty to allow stakeholders to testify. The veterans’ organization stated that this can be seen from the fact that Judge Mulroney postponed the formal hearing process to early 2025 precisely because the DEA provided insufficient information about the position of its selected witnesses on the reclassification of marijuana or why they should be considered stakeholders.
At the same time, the US Congress proposed a new Senate bill this month aimed at ensuring the welfare of veterans who were exposed to potentially dangerous chemicals during the Cold War, including hallucinogens such as LSD, nerve agents, and mustard gas. This secret testing program was conducted from 1948 to 1975 at a military base in Maryland, involving former Nazi scientists administering these substances to American soldiers.
Recently, the US military has invested millions of dollars in developing a new type of medication that can provide the same rapid onset mental health benefits as traditional psychedelic drugs, but without producing psychedelic effects.
Veterans have played a leading role in the legalization of medical marijuana and the current psychedelic drug reform movement at the state and federal levels. For example, earlier this year, the Veterans Service Organization (VSO) urged members of Congress to urgently conduct research on the potential benefits of psychedelic drug assisted therapy and medical marijuana.
Prior to the requests made by organizations such as the American Iraq and Afghanistan Veterans Association, the American Overseas War Veterans Association, the American Disabled Veterans Association, and the Disabled Soldiers Project, some organizations criticized the Department of Veterans Affairs (VA) for being “slow” in medical marijuana research during last year’s annual Veterans Service organization hearing.
Under the leadership of Republican politicians, efforts towards reform also include a psychedelic drug bill supported by the Republican Party in Congress, which focuses on access for veterans, state-level changes, and a series of hearings on expanding access to psychedelic drugs.
In addition, Wisconsin Republican Congressman Derrick Van Orden has submitted a congressional psychedelic drug bill, which has been reviewed by a committee.
Van Oden is also a co proposer of a bipartisan measure aimed at providing funding for the Department of Defense (DOD) to conduct clinical trials on the therapeutic potential of certain psychedelic drugs for active duty military personnel. This reform has been signed into law by President Joe Biden under an amendment to the 2024 National Defense Authorization Act (NDAA).
In March of this year, congressional funding leaders also announced a spending plan that included provisions for $10 million to promote research on psychedelic drugs.
In January of this year, the Department of Veterans Affairs issued a separate application requesting in-depth research on the use of psychedelic drugs to treat post-traumatic stress disorder and depression. Last October, the department launched a new podcast about the future of veterans’ healthcare, with the first episode of the series focusing on the therapeutic potential of psychedelic drugs.
At the state level, the governor of Massachusetts signed a bill in August that focuses on veterans, including provisions to establish a psychedelic drug working group to study and submit recommendations on the potential therapeutic benefits of substances such as psilocybin and MDMA.
Meanwhile, in California, lawmakers withdrew consideration of a bipartisan bill in June that would have authorized a pilot project to provide psilocybin therapy for veterans and former emergency responders.
Post time: Nov-26-2024