MDMA Clinical Research and Forecast for Medical Use

MDMA Clinical Research and Forecast for Medical Use

MDMA (3,4-methylenedioxymethamphetamine) is a synthetic hallucinogen. The street names ecstasy or molly sometimes refer to it, but many of these pills only contain trace amounts of MDMA.

MDMA is a Schedule 1 substance in many countries worldwide. This makes it illegal to produce, possess, and sell.

However, the medical community has urged governments to relook at the drug. MDMA may be an effective medical treatment for several life-threatening mental health conditions. These treatments include:

  • PTSD
  • Anxiety
  • Sexual Dysfunction
  • Alcoholism and Drug Addiction

This article examines:

  • The History of MDMA Research
  • The Application of MDMA in Clinical Trials
  • A List of Current Trials and Research
  • A Short Summary

MDMA Clinical Trials and Studies In the Past

The History of Ketamine

The Early Years: 1912 - 1976

Merck pharmacist Anton Kollisch invented MDMA in Germany in 1912. The company believed it had the potential to help blood clot. It was not tested on humans or animals, and no product containing MDMA made it to market. Still, it was largely forgotten about until 1976 when the chemist and so-called godfather of psychedelics Alexander Shulgin synthesized MDMA and began experimenting with it.

Shulgin's research associate Tony Sargent shared MDMA with psychotherapist Leo Zeff. Leo Zeff had been experimenting with LSD in psychotherapy. When LSD was restricted, Sargent proposed that MDMA might have a similar application. This sparked an era of therapeutic exploration, as detailed in the paper The Early Use of MDMA in psychotherapy (1977-1985) by Torsten Passie.

The Boom: 1977-1985

During 1977-1985, more than half a million doses of MDMA were administered to patients by various independent psychotherapists. Zeff himself trained more than 150 therapists in the uses of MDMA and administered doses to 4000 patients (per Torsten’s Passie paper).

Zeff used MDMA sessions for personal and spiritual development. His therapy consisted of highly ritualized group meditation; whereafter personal experiences were documented. Zeff reported that participants experienced:

  • Enhanced communication during couples counseling.
  • Greater ease in receiving compliments and criticism.
  • Euphoric feelings and positive mood.
  • Greater self-confidence and self-acceptance.
  • Improved creative writing abilities.
  • Better interpersonal communication.
  • Transcendental experiences.

The Association for the Responsible Use of Psychedelic Agents (ARUPA)

In the late 1970s, Richard Price formed the now-defunct Association for the Responsible Use of Psychedelic Agents (ARUPA) hosted in the Esalen Institute, consisting of many proponents for psychedelic drugs in psychotherapy, including David Nichols, Rick Doblin, Jack Downing, Rick Ingrasci, Sasha Shulgin, Leo Zeff, and George Greer.

The group made many advances over the next few years. Greer was one of the first psychotherapists to self-publish a paper on his results, stating that MDMA could enhance communication, intimacy, self-esteem, mood, and a decrease in the consumption of addictive substances. Greer administered MDMA to a number of patients, but only documented two use cases in his paper. The first patient was a man suffering from myeloma, and the second was the daughter of Holocaust survivors experiencing psychological trauma.

The Lost Years: 1985 – 2017

MDMA was criminalized in 1985, which ostentatiously put an end to the ARUPA group’s experimentation. After the scheduling of MDMA, the research moved underground. It’s not known how many therapists continued their work. In his paper, Torsten Passie estimates that more than 60,000 patients may have been treated during this time (based on interviews with ten psychotherapists and eyewitness to psychotherapists practicing illegal MDMA-assisted therapies during this period).

After MDMA was scheduled, psychotherapist Joseph Downing founded the Exuma Island Institute in the Bahamas, officially a stress-relaxation clinic. Downing testified against the scheduling of MDMA in 1985, and continued to use MDMA in sessions conducted on the island. The government closed the clinic after a few months.

Recent MDMA Clinical Trials and Studies

Natural Vs. Synthetic Psychedelics: Which is Better?

MDMA-assisted therapy entered the spotlight again in 2017, with the ground-breaking MAPS study led by one of the original ARUPA members, Rick Doblin. MAPS (Multidisciplinary Association for Psychedelic Studies) was founded in 1986 to make MDMA an FDA-approved medicine.

The MAPS Study on MDMA-assisted Psychotherapy for PTSD

The MAPS study is a Phase III Clinical Trial examining the outcomes of MDMA-assisted therapy. Phase III clinical trials are a required precursor to drugs becoming FDA-approved. The Phase II trial was completed in 2017 and supported the expansion into Phase III, which might lead to the FDA granting Breakthrough Therapy status to MDMA. Phase III will be completed in 2022.

Six randomized, double-blind, controlled trials were conducted from 2004 to 2017. 75-125 mg of MDMA and placebo doses were administered to individuals suffering from PTSD in two to three eight-hour sessions spaced a month apart. Three non-drug ninety-minute therapy sessions preceded the first MDMA exposure, with three or four sessions following each experimental session.

The therapy tested the impact of the treatment on the participants’ CAPS-IV scores (used to measure the severity of trauma).

The results of the study included:

Neurological Effects of MDMA on Mice, Brain Science Institute

study conducted on mice in 2019 and published in the Nature journal (conducted by Romain Nardou of the Solomon H Snyder Department of Neuroscience in the Brain Science Institute) found that the behavior of mice becomes more malleable when injected with MDMA. This suggests that MDMA could assist human beings with unlearning negative behaviors. It hasn’t been tested on humans, but if MDMA assists with unlearning “programmed” behaviors that exist due to trauma it could explain why MDMA is so effective in treating PTSD.

Tel Aviv Study Into MDMA treatment for Sexual Dysfunction

In 2001, researchers Z Zemishlany, D Aizenberg, A Weizman from Tel Aviv University conducted a study among 35 recreational users of MDMA to test the effects of MDMA on sexual function. They found that MDMA increased desire and satisfaction, intensified but delayed orgasms, and enhanced sexual enjoyment. Erection was impaired in 40% of the male participants.

Los Angeles Biomedical Research’s Study in Anxiety Relief for Adults with Autism

LA BioMed completed an exploratory study on the effects of MDMA on social anxiety in adults with autism, led by Charles Grob (MD) in 2014.

The study found that the LSAS scores (measuring social anxiety) were significantly reduced during treatment. It remained the same or marginally improved for participants six months after completing the active treatment phase.

The Imperial College London MDMA-assisted Treatment for Alcoholism

In 2017, the Imperial College London explored the effects of MDMA on alcohol addiction, led by Ben Sessa. Sessa stated that patients with alcohol use disorders usually have a history of psychological trauma that may be alleviated with the use of MDMA.

The first study found that alcohol use decreased significantly for most participants following the trial. Participants consumed 18.7 units of alcohol per week during and after the trial, compared to 130.6 units.

In 2013, Lisa Jerome, Shira Schuster, B Berra Yazar-Klosinski from the MAPS institute penned a paper stating that MDMA could treat substance abuse and related conditions based on past clinical studies trials were conducted.

MDMA-Assisted Therapy for Eating Disorders (MAPS)

MAPS plans to conduct a multi-site Phase 2 for MDMA as an adjunct to therapy for anorexia nervosa and binge-eating disorders.

Conclusion

With final FDA approval imminent, MDMA may soon become available to the general public via prescription. The clinical trials for MDMA-assisted therapy and other treatments show great promise, offering a lifeline to individuals who have PTSD.

It is worth noting that the MDMA used in clinical trials are synthesized specifically for that purpose and that street drugs like ecstasy or Molly may not contain MDMA at all. If you are unsure whether you have purchased pure MDMA or not, testing kits can help detect harmful adulterants.

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