MDMA proves a promising alcoholism treatment in world-first trial

A new study published in the Journal of Psychopharmacology is reporting on a landmark clinical trial exploring the potential for MDMA-assisted psychotherapy in treating subjects with alcohol use disorder. The small open-label trial is the first to test MDMA therapy as a treatment for addiction and the results suggest it is safe, well-tolerated and significantly more effective than any current treatment for alcoholism.

3,4-Methylenedioxymethamphetamine, or MDMA, was originally synthesized in Germany in 1912 but spent much of the 20th century as an unexplored footnote in chemistry journals. The drug was rediscovered by psychonauts in the 1960s, and psychotherapists quietly explored its therapeutic potential before its use spiraled into recreational circles, eventually becoming illegal in the early 1980s.

Over the past few decades, a small community of dedicated researchers has worked to legitimize the drug and re-establish its medical uses. Leading the way has been robust work showing the drug to be significantly effective treating PTSD. Now deep in Phase 3 clinical trials, MDMA-assisted psychotherapy for PTSD is just a year or two away from market approval in the United States.

For the last few years psychiatrist Ben Sessa and a team of UK researchers have been exploring the role of MDMA therapy in treating alcohol use disorder (AUD). In a newly published study the researchers report on the world’s first trial testing the novel treatment on patients suffering from addiction.

This small, proof-of-concept study recruited 14 subjects with AUD. The goal of this preliminary study was to establish a safety profile for the MDMA therapy in patients suffering from AUD, but an expansive nine-month follow-up period also allowed for a unique insight into the possible long-term efficacy of the treatment.

The trial used a protocol similar to that being explored by MDMA for PTSD research. The course of treatment spans eight weeks and comprises 10 psychotherapy sessions. Two of those sessions involve day-long MDMA treatments, while the other sessions are more traditional one-hour psychotherapy appointments.

In regards to tolerability and safety, the study reports no adverse responses to the drug were detected either during a treatment session or in the days following. In a fascinating side note, the study followed each subject’s acute mood state for seven days after each MDMA session.

Recreational MDMA users have for years frequently reported negative mood swings around two to three days after using the drug. Anecdotally referred to as "Terrible Tuesdays," pseudoscientific explanations have often suggested some kind of serotonin depletion can take hold in the days following MDMA use, causing a unique kind of depressive hangover.

The new research specifically addresses this anecdotal phenomenon and suggests when MDMA is delivered through a clinical therapeutic program this anecdotal post-drug hangover is not detected. Sessa hypothesizes this common recreational observation is more due to polydrug use and other confounding factors instead of the MDMA itself.

“No come-downs or post-drug affect drops for 7-days post MDMA,” Sessa notes on Twitter. “Blue Monday/Black Tuesday/so-called ‘Suicide Wednesday’ reported by ravers are myths due to confounding hangover factors; not MDMA.”

Although the primary goal of the trial was to understand safety issues with the MDMA therapy in AUD patients, the extensive follow-up period allowed for some compelling insights into how long-term drinking behaviors were affected.

Nine months after the trial only 21 percent of the cohort were drinking more than 14 units of alcohol per week. This compares to an average of 130 units of alcohol consumed per week by each patient before detox at the beginning of the study.

As this was not a placebo-controlled trial, the researchers did conduct a small adjacent study to look at how MDMA therapy compares to current gold-standard treatments for AUD.

Fourteen subjects were recruited and tracked for nine months following detox for this adjacent outcome study. A striking 75 percent were consuming more than 14 units of alcohol per week at the nine-month follow-up point. This data resembles the generally poor long-term outcomes for current AUD treatments, which register drinking relapse rates at around 60 percent one year after treatment and 80 percent three years later.

It is important to note this is still very preliminary research. A larger Phase 2b placebo-controlled trial run by burgeoning psychedelic biotech company Awakn Life Sciences is getting underway in the United Kingdom to more comprehensively explore the efficacy of MDMA therapy for AUD. Sessa, chief medical officer for Awakn, suggests this stage should take around three years.

In the meantime, prospective clinics around the world are preparing for MDMA/PTSD treatments to be approved, establishing the infrastructure necessary to administer multiple forms of psychedelic therapies for a variety of conditions, including psilocybin for depression. MDMA therapy for alcoholism may still be a few years away from clear clinical validation, but this proof-of-concept trial is as strong a first study as one could hope for.

The new research was published in the Journal of Psychopharmacology.

Source: Awakn Life Sciences