The Department of Veterans Affairs (VA) on Tuesday announced a new clinical trial of methylenedioxymethamphetamine-assisted therapy, more commonly known as MDMA, to evaluate the safety and efficacy when treating current and former military personnel for severe mental health disorders including posttraumatic stress disorder (PTSD) and alcohol use disorder.
The latest announcement comes on the heels of a strong federal government-wide push across multiple branches to study and, ultimately, lawfully recognize different modalities like MDMA, psilocybin, LSD and ibogaine. Legislation has been crafted on bipartisan levels in both the U.S. House and Senate to accelerate the pace for which the VA, Food & Drug Administration (FDA) and the Department of Health and Human Services (HHS) can collectively give the green light for more widespread use in controlled settings.
“We need an all-of-the-above strategy when it comes to improving mental health treatments, and under President Trump, that’s exactly what VA is working to deliver,” VA Secretary Doug Collins said in a statement. “This trial represents an important step in safely evaluating new approaches and innovations to treat Veterans with severe mental health conditions.”
Support for such modalities has come from President Donald Trump himself, who in April signed an executive order calling on the FDA to facilitate access to psychedelic drugs, including ibogaine compounds, psilocybin, ketamine, LSD and MDMA, for eligible patients suffering from major depressive disorder and substance abuse disorders. Such drugs remain federally illegal in recreational settings.
Trump said April 1 in the Oval Office that such therapies should provide individuals the “chance to reclaim their lives and lead a happier life.”
Progress has seemingly been too slow for some lawmakers, based on recent correspondence to the FDA. On May 1, a letter signed by 32 House Republicans and Democrats—led by Reps. Jack Bergman (R-MI) and Lou Correa (D-CA), co-chairs of the Congressional Psychedelics Advancing Therapies Caucus—was sent to FDA Commissioner Marty Makary urging the agency to advance its evaluation of rapid-acting novel therapeutics.
Answers provided to those on Capitol Hill could now take even longer, considering that Makary resigned on May 12 following a 13-month tenure as FDA chief. Reports suggested that he and the White House had personal disagreements over policies, including Makary’s alleged disagreement about making vaping and e-cigarette products more widely accessible.
How MDMA Trial is Being Conducted
The VA’s latest trial, titled “A Randomized Controlled Trial of MDMA-Assisted Therapy for PTSD and Alcohol Use Disorder in U.S. Veterans,” will enroll approximately 80 veterans. Results will compare outcomes between those receiving MDMA-assisted therapy and those receiving identical psychotherapy with an active placebo, according to the agency in a statement released Tuesday.
VA is coordinating with the U.S. Food and Drug Administration (FDA) and intends to share data from the trial with FDA.
The randomized, placebo-controlled trial will take place at VA Providence Healthcare System. Veterans participating in the trial are being recruited from the Providence, R.I., campus and VA Connecticut Healthcare System in West Haven, Conn. The VA is coordinating the trial with the FDA, and intends to share data with that agency.
Citing veterans’ health and safety, the VA said that investigational treatments “will be delivered in a safe, controlled, clinical setting using pharmaceutical grade drugs under careful quality controls, stringent safety protocols that were developed with FDA, and in a setting that includes structured psychotherapy.”
The VA is currently involved in 19 active clinical trials focused on psychedelic therapies for mental health conditions, supported by more than $23 million in external funding.
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