FDA Approves Phase 2 Trial of Smoked Cannabis for PTSD in Veterans

The FDA has approved a groundbreaking phase 2 clinical trial to investigate the effects of smoked cannabis in veterans with post-traumatic stress disorder (PTSD). The study, one of the largest of its kind, aims to evaluate the safety and efficacy of inhaled THC cannabis flower in alleviating symptoms of moderate-to-severe PTSD.

A Lifeline for Veterans with PTSD

Veterans are disproportionately affected by PTSD. While approximately 6% of U.S. adults are diagnosed with the condition, over 23% of military service members experience PTSD, often stemming from combat exposure and pre-existing mental health conditions.

Dr. Sue Sisley, the principal investigator and president of the Scottsdale Research Institute (SRI) Foundation, emphasized the urgency of finding effective treatments.

“Our veterans are in dire need of treatments that can ease their challenging symptoms of PTSD,” Sisley said. “Many have shared that smoking cannabis has helped them manage their symptoms better than traditional pharmaceuticals. Suicide among veterans is an urgent public health crisis, but it’s solvable if we invest in researching new treatments for life-threatening health conditions like PTSD.”

The trial seeks to address this gap by rigorously testing cannabis as an alternative therapy for PTSD.

What the Study Entails

The study will enroll 320 veterans diagnosed with moderate-to-severe PTSD who have prior experience using cannabis. Participants will use inhalation THC dried cannabis flower, while a control group will use placebo cannabis. Researchers aim to determine the safety of self-titrated doses, mimicking real-world cannabis use.

Key details of the trial include:

• Participant Demographics: Veterans with moderate-to-severe PTSD.
• Intervention: Smoked cannabis with high THC potency, reflecting commercially available products in states where cannabis is legal.
• Control Group: Placebo cannabis.
• Funding: The study is supported by the Michigan Veteran Marijuana Research Grant Program.

The trial, named MJP2, is being conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS), a leading research organization focused on the therapeutic potential of psychedelics and marijuana.

Scientific Rationale: How Cannabis May Help

Cannabis contains tetrahydrocannabinol (THC), which interacts with receptors in the brain linked to memory, fear, and inflammation. Research suggests THC could help modulate these systems, reducing PTSD symptoms such as anxiety, flashbacks, and sleep disturbances.

Regulatory Challenges and Breakthroughs

The FDA initially placed the trial on partial clinical hold in 2021, citing concerns over dosing protocols and safety. After a Formal Dispute Resolution Request (FDRR) was filed in August 2024, MAPS successfully addressed the agency’s concerns.

One key issue was allowing participants to self-titrate their cannabis doses, a practice that mirrors real-world usage. Following discussions, the FDA approved this approach, enabling the trial to move forward.

Allison Coker, Ph.D., MAPS’ director of Cannabis Research, noted the significance of resolving these issues. “The collaboration with the FDA ensures we can rigorously study cannabis in a way that aligns with how people use it in their daily lives,” she said.

Hope for a Better Future

As the U.S. grapples with high rates of veteran suicide and mental health crises, this study offers hope for a novel treatment option. By investigating cannabis’ potential to improve PTSD symptoms, the trial could pave the way for a safer, more effective alternative to traditional pharmaceuticals.

With veterans at the center of the research, the findings could have a profound impact, not only on PTSD treatment but also on public perceptions of cannabis as a therapeutic option.