Cusp of breakthrough: clinical trial data suggest efficacy of MDMA therapy for PTSD

Clinical trials of MDMA psychotherapy are going on at 15 sites in the U.S., Canada, and Israel

MDMA, which goes by street names ‘ecstasy’ and ‘molly’, triggers the release feel-good chemicals in the brain.. PORTOKALIS/GETTY IMAGES

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The synthetic drug MDMA is a step closer to becoming legal medicine.

An interim analysis of data from an ongoing clinical trial suggests that MDMA, which goes by the street names “ecstasy” and “molly”, is effective in treating symptoms of PTSD, or posttraumatic stress disorder.

The trial involving the chemically derived MDMA, or “3,4-methylenedioxymethamphetamine”, is ongoing in the U.S., Canada, and Israel.

The study is being conducted by the California-based Multidisciplinary Association for Psychedelic Studies.

The nonprofit research organization announced the results of an interim analysis of data from its clinical trial in a media release Tuesday (May 12).

According to the MAPS release, the analysis “revealed a 90% or greater probability that the trial will detect statistically significant results when all participants have been treated”.

MAPS founder and executive director Rick Doblin noted that the results of the interim analysis represent “the most powerful evidence yet that MDMA-assisted psychotherapy could help transform the lives of people suffering from PTSD”.

The MAPS release stated that the nonprofit has partnered with the Psychedelic Science Funders Collaborative, or PSFC, to raise a fund of $30 million to complete the research on MDMA treatment for PTSD sufferers.

PSFC cofounder and president Joe Green said that psychedelic medicines “show incredible promise for treating a range of mental health conditions”.

“This first look at data from the first-ever Phase 3 trial of a psychedelic-assisted therapy only makes us more confident that we’re standing on the cusp of a breakthrough,” Green said.

Phase 3 clinical trials are generally required before the U.S. Food and Drug Administration (FDA) approves the public use of a new drug.

“The approval of MDMA-assisted psychotherapy would be a catalytic event that brings psychedelic medicine into the mainstream,” Green said.

PTSD is a serious mental-health condition among people who have experienced or witnessed a dangerous event.

Traumatic events that cause this disorder include death, violence, and natural disasters.

In Canada, MDMA is banned under the Controlled Drugs and Substances Act.

Sale, possession, and production of MDMA are illegal in the country, unless these activities are authorized for medical, scientific, or industrial purposes.

The federal government of Canada notes online that MDMA is being studied for its “potential to treat conditions such as anxiety and post-traumatic stress disorder”.

“These studies use medical-grade MDMA in clinically supervised settings,” according to the government.

Ecstasy and molly are often consumed at parties and music festivals.

The drug makes the brain release serotonin and dopamine, which the Government of Canada’s website describes as “‘feel-good’ chemicals”.  

In August 2017, MAPS announced that the FDA had granted breakthrough therapy designation to MDMA for the treatment of PTSD.

The designation allows MAPS to design two Phase 3 clinical trials of MDMA-assisted psychotherapy for patients with severe PTSD.

“MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct,” the nonprofit explained at the time.

In the 2017 media release, MAPS founder Doblin noted that this would be the “first time ever” that “psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way”.

For the study, MDMA is administered in three single-dose psychotherapy sessions in a clinical setting.

MAPS explained in its May 12 media release that once MDMA is approved for general-public use, patients will neither fill prescriptions at the pharmacy nor take the drug home.

“Instead, MDMA-assisted psychotherapy treatment will only be available through a doctor and only in supervised therapeutic settings from certified clinicians,” the nonprofit explained.

MAPS Phase 3 trials are expected to be completed in 2021.

According to the organization, the FDA could potentially “approve the treatment as early as 2022”.

Follow Carlito Pablo on Twitter at @carlitopablo

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