Clinical trials suggest treatment that involves psychedelics can be more effective than psychotherapy alone.

More than three million people in the United States are diagnosed each year with post-traumatic stress disorder, whose symptoms include nightmares or unwanted memories of trauma, heightened reactions, anxieties, and depression--and can last months, or even years.

People with PTSD--difficulty recovering from experiencing or witnessing a traumatic event--have traditionally been treated with a combination of trauma-focused psychotherapy and a regimen of medications. Many sufferers have not responded well to that treatment, but new research to be presented by the Medical University of South Carolina's Dr. Michael Mithoefer and colleagues, at the annual meeting of the American College of Neuropsychopharmacology, suggests that the combination of some psychedelic drugs and traditional psychotherapy holds promise.

Psychedelic substances are often found in nature and have been used in various cultures over thousands of years. Formal medical research into their medicinal uses starting in the 1950s produced promising results published in major journals but was largely halted in the 1970s for political rather than medical or scientific reasons. More recent studies argue that, when administered in a controlled clinical setting, MDMA (more commonly known as ecstasy) and psilocybin (the active ingredient in "magic mushrooms") have acceptable risk profiles --and patients who experienced temporary adverse reactions did not require additional medical intervention.

In the past few years the FDA has granted both MDMA and psilocybin Breakthrough Therapy Designations for PTSD and depression respectively, acknowledging they may improve upon existing therapies, and agreeing to expedite their development and review.

The research by Dr. Mithoefer and his team includes six Phase 2 clinical trials conducted by independent investigators in four countries. In the trials, one group of patients was administered MDMA during their psychotherapy sessions, while the other group was administered a placebo or low dose comparator in conjunction with the same psychotherapy. The overall conclusion from these studies was that MDMA-assisted psychotherapy was significantly more effective at treating patients with persistent PTSD than unassisted psychotherapy.

The researchers aim to both review the successes that have been seen in the use of psychedelic drugs to treat trauma-related disorders and depression, as well as address several of the outstanding questions the medical community may still have concerning the safety, efficacy, and neurobiological functions of these novel treatment options.

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The findings were presented at the 58th Annual Meeting of The American College of Neuropsychopharmacology (ACNP) in Orlando, FL, December 8-11, 2019.