As the federal government’s interest in psychedelic use for mental health conditions continues to grow, the Department of Veterans Affairs is launching a clinical trial evaluating MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder.
The randomized, placebo-controlled study will enroll approximately 80 veterans and compare outcomes between participants receiving MDMA-assisted therapy and those receiving identical psychotherapy with a placebo.
Studies have found that 40% to 60% of PTSD patients do not respond adequately to current therapies. PTSD is currently treated with psychotherapy and two FDA-approved medications, sertraline and paroxetine.
Here are five things to know:
- In research settings, MDMA is administered during a limited number of supervised treatment sessions and is paired with psychotherapy, according to the VA. Patients typically undergo preparatory sessions before treatment and integration sessions afterward. Medication sessions generally last six to eight hours and may be repeated one to three times over approximately 18 weeks.
- Although effective treatments for PTSD exist, researchers continue to explore whether MDMA may help more patients benefit from psychotherapy. MDMA can produce feelings of connection, empathy and emotional openness while the drug is less likely to create hallucinations than other psychedelic substances.
- In 1985, MDMA was classified as a Schedule I substance under federal law, meaning it has a high potential for abuse and no accepted medical use. The drug can be administered only in approved clinical research studies.
- Reported side effects in research settings are generally mild to moderate and temporary. Common side effects include elevated heart rate and blood pressure, anxiety, muscle tightness, nausea, sweating and restlessness. Researchers note that MDMA administered in clinical studies differs significantly from recreational use because treatment occurs under medical supervision and alongside psychotherapy.
- In 2017, MDMA-assisted psychotherapy received FDA Breakthrough Therapy designation for treatment-resistant PTSD, a status intended to expedite development and review of therapies that may offer substantial improvement over existing treatments.
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