After years of back and forth, the U.S. Food and Drug Administration (FDA) approved a clinical trial to determine whether cannabis helps veterans with post-traumatic stress disorder (PTSD).
This critical multi-state study, dubbed MJP2, will include more than 300 participants. The researchers argue it will connect the dots between real-world cannabis use and scientific theory. This connection could bring hope to the thousands of veterans struggling with PTSD.
The FDA’s Division of Psychiatry Products greenlit the study after a hold in 2021 over regulatory concerns. But MAPS appealed the decision, which paved the way for the recent approval.
A PTSD Breakthrough, Despite Challenges
Specifically, the researchers say that MJP2 will assess the inhalation of high-THC cannabis flower against that of a placebo, with participants self-titrating their daily doses, in a bid to replicate real-world usage.
But regulatory hurdles persisted. Over three years, the FDA issued five partial clinical hold letters, each addressing concerns about:
- The proposed dosage.
- The delivery method.
- The inclusion of cannabis-naïve participants.
- And the use of vaporization devices.
In response, MAPS submitted a Formal Dispute Resolution Request (FDRR), challenging these objections.
“Despite the widespread use of cannabis labeled as ‘medical’ in many states, there’s a lack of high-quality, controlled data that reflects real-world consumption patterns,” MAPS’ Director of Cannabis Research Allison Coker, Ph.D., said in a press release. “MJP2 aims to provide critical safety and efficacy data to inform patients, providers, and policymakers about the risks and potential benefits of cannabis in managing PTSD and other serious health conditions.”
Finally, regulators allowed MJP2 to proceed with its self-titration dosing approach. This let participants use the drug at THC potency levels similar to what they could buy in legal markets. While the FDA held fast to its curbs on cannabis-naïve participants, MAPS revised the study protocol to accept only participants who had previous cannabis experience.
Tackling an Urgent Need
The study holds particular significance for Veterans, who face alarmingly high rates of PTSD and suicide. Traditional treatments often fall short, leaving many to turn to cannabis for relief.
“Veterans are in dire need of treatments that can ease their challenging symptoms of PTSD,” said Sue Sisley, MD, Principal Investigator for MJP2. “In my practice, many Veterans have reported that smoking cannabis provides more relief than traditional pharmaceuticals. This study will generate the high-quality data we need to develop evidence-based treatment plans.”
Funded by the Michigan Veteran Marijuana Research Grant Program, MJP2 isn’t just about understanding cannabis use. By studying inhaled cannabis in a controlled setting, researchers wanted to explore its potential benefits and risks, contributing to a better understanding of its role in future treatment.
A Regulatory Sea Change?
MAPS’ persistent advocacy for cannabis research also telegraphed a larger shift in the FDA’s approach to cannabis research. The agency’s willingness to rethink its position reflects a broader recognition of the dearth of cannabis data.
MAPS Found and President Rick Doblin, Ph.D., touted the regulatory milestone.
“For over 15 years, we’ve pushed the FDA to think differently about novel treatments like MDMA-assisted therapy,” he said. “Now, with cannabis, we’re challenging their conventional approach to dosing and administration to ensure research reflects real-world use.”
While the FDA remains cautious about certain aspects of the study — such as the use of vaporization devices, which is still dependent on better safety data – MJP2 still represents a huge step forward.
The data from this study won’t just enlighten medical professionals but it should also pave the way for future cannabis research on a variety of health conditions.
The trial also highlights the need to move beyond historically intransigent perspectives on cannabis, and accept more evidence-based understanding. Millions of Americans already use cannabis to manage minor health symptoms, but most of the (admittedly scarce) data out there is skewed. Studies like MJP2, should help move the narrative forward.
“This research is about more than just cannabis — it’s about opening doors for innovative treatments and providing our Veterans with the care they deserve,” Sisley added. “MJP2 is a critical step in making that a reality.”
