Multi-National & Multi-Site PTSD-based Clinical Trial Leads to FDA Expansion of Access to Ecstasy

Jan 28, 2020 | CNS, Ecstasy, MDMA, Post Traumatic Stress Disorder, PTSD, Stress, The Multidisciplinary Association for Psychedelic Studies

Multi-National & Multi-Site PTSD-based Clinical Trial Leads to FDA Expansion of Access to Ecstasy

Because of successful clinical trials including those in Mount Pleasant, South Carolina conducted by therapist Michael Mithoefer, the Food and Drug Administration (FDA) have expanded the use of ecstasy guided therapy—known as MDMA—which is an illegal drug often associated with rave parties and club kids in the past. Studies will be expanded to potentially aid firefighters, police officers, and soldiers trying to combat long-standing trauma and stress. The Multidisciplinary Association for Psychedelic Studies, a non-profit organization that Mithoefer serves as the acting director of, received the green light from the FDA to extend the treatment to those with “a serious or life-threatening condition for whom currently available treatments have not worked.”

The Problem

The U.S. has essentially been involved with some form of continual military intervention or presence in the Middle East since 2003—this represents the longest such spans in U.S. history, unless one counts the Cold War. One outcome of such ongoing conflicts include PTSD, which many active-duty service members and veterans experience. The Department of Veterans Affairs (VA) estimates that 11 to 20% of veterans who served in the wars in Iraq and Afghanistan have PTSD, compared to about 7 to 8% of the general population. Generally, the government has taken a conservative stance on substances such as MDMA—listing as a Schedule 1 substance. Hence a stigma is created, and for those pursuing novels and hopefully legal uses, the effort isn’t easy or necessarily straightforward.

The Research Site

The Multidisciplinary Association for Psychedelic Studies, (MAPS) based in Santa Cruz, CA, was founded in 1986 as a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.

A Patient Story

Mithoefer has been working with dozens of veterans, including Army Sgt. C.J. Hardin. The West Ashley, SC resident served in Iraq and Afghanistan for eight years. The stress of war paired with memories from his childhood haunted him, according to Thomas Novelly, writing for The Post and Courier. Hardin fell to drinking and self-medication with cannabis in understandable attempts to numb the pain. In what often happens in this kind of scenario, he became more isolated, more removed from social circumstances and started evolving into a hermit. Hardin was quoted in The Post and Courier “It was a culmination of events in my life, but it got more intense during my deployment.” He continued, “There was this general feeling of not feeling safe at any time. The sounds of rockets and mortars and knowing that at any moment, a bomb could come in on you.” Hardin has been through the study and is thoroughly grateful, noting he isn’t sure he would still be alive today but for the study led by Mithoefer.

Clinical Studies Summary

Finally, the FDA allowed limited controlled studies where patients take the substance, in a controlled and clinical setting, in a pure form provided by the FDA or a placebo. They are given eyeshades, music to listen to, and a quiet place to stay overnight. Therapists follow up with multiple sessions to discuss feelings and emotions before the next administered dose reports Novelly. One Phase II trial ultimately led to 68% of the patients no longer exhibit PTSD symptoms. 22 of the 26 participants in this study were veterans.

By 2017 the FDA issued the green light to investigators to proceed to Phase III. These studies will be completed in 2021, which means an FDA approval could happen by 2022. Mithoefer reports that 56 patients have been involved with the trials.

Published Phase III Study

The Published Phase III study is recorded in ClinicalTrials.gov as a multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy versus psychotherapy with placebo in participants diagnosed with at least severe post-traumatic stress disorder (PTSD).

The study is conducted in up to N ≈ 100 participants. Participants are randomized to receive a flexible dose of MDMA or placebo, followed by a supplemental half-dose, unless contraindicated, during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure changes in the Clinician-Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline.

Exploratory measures are used to address specific symptoms or behavior that are sometimes related to PTSD. Drug safety is assessed by measuring blood pressure, heart rate, and body temperature during experimental sessions, collecting adverse events, and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (CSSRS).

The study compares the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA versus placebo. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate or placebo alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental half-dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

Research Sites

A number of sites are involved in Israel, Canada and multiple locations in the United States. The Principal Investigator for the entire worldwide study is Michael Mithoefer, MD, with the sponsor MAPS.

Lead Research/Investigator

Michael Mithoefer

Call to Action: Have you or a loved one been diagnosed with severe PTSD? Consider looking into this study and ongoing results.

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