FDA Greenlights Clinical Trials to Study Cannabis for PTSD Treatment

Washington, DC In a surprise move, the Food and Drug Administration has authorized the Multidisciplinary Association for Psychedelic Studies (MAPS) to conduct clinical trials to study the effectiveness of smoking cannabis to treat post-traumatic stress disorder in veterans. It is no secret that veterans with PTSD commonly use marijuana to manage their symptoms when other medications are ineffective. Until now, however, there has been no scientific evidence as to its safety and effectiveness.

Veterans who suffer from undiagnosed or under-treated mental health conditions have long complained of VA medical malpractice at understaffed and overburdened facilities. An additional treatment option may ease some of the bottle neck.

Clinical trials

According to the FDA, the five-week study will follow 320 participants diagnosed with moderate to severe PTSD who will smoke cannabis at home and then rate their PTSD symptoms by using an app that they download on their cell phone or another mobile device.

Veterans will receive active cannabis or a placebo. The study is double-blind, which means that the veterans and their clinicians will not know which dose they are receiving. The subject’s PTSD symptoms will be assessed at the start and end of the treatment. Former service members selected for the clinical trials must have prior experience smoking cannabis. They also must agree to limit their cannabis use to the doses provided for the study. MAPS is still in discussions with the FDA about when the trials will start. Sites in Michigan, Arizona and Florida are under consideration for the trials, including VA facilities. Veterans will not undergo mental health counseling as part of the study.

According to its website, the “FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”

Crumbling roadblocks?

Until recently, the federal government has prioritized research on the harms of marijuana. But legalization, and the tax revenue that followed, has left states with financial resources to expand research into marijuana’s efficacy for therapeutic uses.

From the viewpoint of the federal government, however, cannabis remains classified as a Schedule I drug. Schedule I is the government’s most restrictive category, reserved for drugs seen to be highly prone to abuse and without proven medicinal value. The classification created formidable regulatory, legal and financial constraints that have stymied the kind of rigorous studies health regulators and doctors rely on.

The classification has not changed, although proposals have been floated. But public attitudes seem to have shifted. The likelihood of reclassification is uncertain, given the impending change in administration.

PTSD and veterans

PTSD is a mental health condition that causes anxiety, anger and flashbacks in individuals who have experienced terrifying events. People with PTSD might experience nightmares, depression, negative thoughts, flashbacks, hypervigilance, and avoidance behaviors.

In 2021, according the VA, about 11 percent of veterans were diagnosed with PTSD. The condition is more common among female veterans, with a diagnosis rate of 13 percent. (Some speculate that this may be a consequence of military sexual trauma.) The numbers run much higher for Vietnam war veterans, estimated at 30 percent.

VA Health System falls short

Veterans’ acute need for timely PTSD diagnosis and treatment runs headlong into a health system that can be charitably described as “struggling.” In 2024, according to the Military Officers Association of America, the VA medical system has again been placed on the GAO's "high risk" list, a biennial compilation that names federal programs and operations that struggle with waste, fraud, abuse, mismanagement or need transformation. The system has been on the list since 2015.

Medical malpractice, which may include instances of:

• misdiagnosis;
• treatment errors;
• failure to monitor; or
• outright denial of care,

can have devastating effects for veterans suffering from PTSD. Medical malpractice can also erode trust in the VA healthcare system, making it harder for veterans to seek the help they need, or to turn to self-medication.

Some of the stories are tragic, ending in suicide, self-harm or violence toward others – the veteran with suicidal ideation who was left alone in an examining room for hours, the veteran whose untreated mental health struggles allegedly played out in sexual violence toward children. They are also all too well-known.

Cannabis therapies will certainly not solve all these issues, nor will it fix the VA. Nonetheless, it seems appropriate to explore additional treatment options.

Veterans' rights and legal recourse

Veterans who believe they have been victims of medical malpractice at VA hospitals have legal rights and options for seeking compensation. These include:

• Federal Tort Claims Act (FTCA): The FTCA is a federal law that allows individuals to sue the federal government for certain types of negligence, including medical malpractice. Veterans who believe they have been harmed by VA medical providers may be able to file a claim under the FTCA.
• VA Benefits: Veterans may be eligible for disability benefits from the VA if their PTSD is service-connected. It is important to understand how medical malpractice claims may impact these benefits.