First, it was LSD - earlier research found that LSD might decrease anxiety symptoms in certain circumstances.

Now it's Ecstasy - new research shows that Ecstasy, or Molly – officially known as MDMA (3,4-methylenedioxymethamphetamine) - may also have beneficial aspects to it.

MDMA is typically thought of as an illicit street drug with potent effects1. According to Drugabuse.gov, it produces feelings of increased energy, pleasure, and emotional warmth as well as hallucinogenic effects, including distorted sensory and time perception. These effects have made MDMA a popular drug among partygoers, who take it to enhance their experience at clubs, concerts, and raves. As one might expect from an illegal drug, though, it also has a number of negative side effects, including but not limited to irritability, increased aggression, depression, anxiety, and problems with memory or attention2.

Furthermore, taken in large doses, MDMA can result in body temperature spikes that can cause liver, kidney, or heart failure – all of which can lead to death. In 2011 alone, MDMA resulted in over 22,000 emergency room visits3. Given its dangerous nature, the United States Drug Enforcement Administration (DEA) currently classifies MDMA as a Schedule 1 substance – a drug with no medically redeeming qualities and a high potential of abuse4.

With all the above in mind, you might be surprised to learn that the FDA announced last month that it had approved MDMA for Phase 3 clinical trials for the treatment of PTSD5-6. As it turns out, MDMA has a long history of being used in therapeutic contexts, with clinicians using it to enhance psychotherapy7. Though initial reports seemed promising, this research was cut short when MDMA was banned in 1985. After years of petitioning by organizations such as the Multidisciplinary Association for Psychedelic Studies (MAPS), federal agencies have begun to loosen restrictions on such controlled substances, and researchers have begun the initial clinical trials necessary to investigate MDMA as a treatment for PTSD.

For many years, researchers had speculated that MDMA might be particularly helpful in treating PTSD by helping patients process their traumatic memories in a clinical setting8. Specifically, the warm, positive feelings induced by MDMA could increase the amount of trust that patients feel towards their therapist, and the sensory enhancing effects could lead to more effective processing of their traumatic memories9. Such effects could help patients to re-experience and re-evaluate their memories, perhaps reducing the amount of stress they cause.

Thus, MDMA is used in a very different way than typical psychoactive medications. Whereas a medication like a selective serotonin reuptake inhibitor (SSRI) might be taken daily over the course of months or years, MDMA-based therapies administer the drug in 2-3 carefully controlled sessions, with two trained therapists leading patients through their experience. A crucial piece of the puzzle is ensuring that patients feel a strong bond and trust in their therapists prior to beginning treatment with MDMA. Consequently, it's not that MDMA has therapeutic qualities on its own but that it can be used in a therapeutic context to greatly enhance otherwise normal therapy sessions.

Research investigating MDMA has been promising. Initial studies that found that, in a controlled therapeutic setting, MDMA was safe for humans10. Following that, clinical trials began examining whether MDMA-assisted therapy could help patients with PTSD. The first study in this series found that 83% of subjects who received MDMA-assisted therapy reported significant improvements in their symptoms11. In fact, three individuals who, despite years of previous therapy, had not been able to work due to their symptoms, were able to return to work after the study ended. The researchers followed-up with these initial patients and found that at least 74% of the patients studied (14 out of 19) "demonstrated meaningful, sustained reductions" in their symptoms of PTSD up to 3-1/2 years after treatment12. Perhaps what is most impressive about these findings is that, in order to qualify for this study, patients had to have had years of previous therapy attempts. In other words, all of these patients had treatment-resistant PTSD. And yet, they experienced significant, long-term improvements in their symptoms through this new treatment.

As with any new treatment, much more research is needed. For instance, the researchers did not directly compare the MDMA-assisted therapy to other known treatments, such as SSRIs or cognitive behavioral therapy (CBT). Furthermore, these studies had extremely small sample sizes (a maximum of 22 patients), meaning that it is unclear how these effects will generalize to other contexts and populations. However, that is precisely why the FDA approved Phase 3 clinical trials – to enable researchers to begin larger scale testing to better evaluate the effectiveness of MDMA-assisted therapy.

Despite the preliminary nature of these findings, this work is extremely exciting. This treatment not only seemed to work as good as, if not better, than previously approved therapies, but patients experienced few negative side-effects and all reported that the treatment had an overall positive effect on their lives12. Furthermore, taking MDMA within the therapeutic sessions did not increase the chances of patients taking other illegal drugs, which had been a major concern for researchers who worried that exposure to MDMA could serve as a gateway to other substances. Because the results have been so promising, researchers have begun petitioning the FDA for what is known as Breakthrough Therapy Designation for MDMA. In short, this designation would allow for much more rapid approval of MDMA for treatment, allowing it to be prescribed as soon as 2021.

To reiterate, MDMA can be a very dangerous drug – especially given that illegal versions can contain much more harmful substances13. However, we are finding that in the proper therapeutic contexts, it may have potentially life-saving consequences for individuals suffering from PTSD.

Date of original publication:

Sources

1. European Monitoring Centre for Drugs and Drug Addiction. Methylenedioxymethamphetamine (MDMA or 'Ecstasy') drug profile. Retrieved December 10, 2016 from http://www.emcdda.europa.eu/publications/drug-profiles/mdma

2. Denver DA. Ecstasy Health issues. Retrieved December 10, 2016 from http://www.denverda.org/prosecution_units/drug_court/Ecstasy_Health_Issues.htm

3. Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. Retrieved December 10, 2016 from http://archive.samhsa.gov/data/2k13/DAWN2k11ED/DAWN2k11ED.htm

4. Drug Enforcement Administration. Drug Schedules. Retrieved December 10, 2016 from https://www.dea.gov/druginfo/ds.shtml

5. Philipps, D. (2016, November 29). F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients The New York Times. Retrieved from http://www.nytimes.com/2016/11/29/us/ptsd-mdma-ecstasy.html?_r=1

6. Sheikh, K. (2016, November 30). MDMA could be on the market legally by 2021. MSN News. Retrieved from http://www.msn.com/en-us/news/us/mdma-could-be-on-the-market-legally-by-2021/ar-AAkY1X5

7. Greer, G. R., & Tolbert, R. (1998). A method of conducting therapeutic sessions with MDMA. Journal of psychoactive drugs, 30, 371-379.

8. Sessa, B. (2011). Could MDMA be useful in the treatment of post‐traumatic stress disorder?. Progress in Neurology and Psychiatry, 15, 4-7.

9. Mithoefer, M. C., Jerome, L., Doblin, R., & Gibson, E. (2003). MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder. Retrieved from https://www.researchgate.net/publication/242431304_RE_MDMA_Assisted_Psychotherapy_for_the_Treatment_of_Post_Traumatic_Stress_Disorder

10. Bouso, J. C., Doblin, R., Farré, M., Alcázar, M. Á., & Gómez-Jarabo, G. (2008). MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder. Journal of psychoactive drugs, 40, 225-236.

11. Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., & Doblin, R. (2011). The safety and efficacy of±3, 4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Journal of Psychopharmacology, 25, 439-452.

12. Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., Martin, S. F., Yazar-Klosinski, B., ... & Doblin, R. (2012). Durability of improvement in posttraumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3, 4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Journal of Psychopharmacology, 0269881112456611.

13. National Institute on Drug Abuse. DrugFacts – MDMA (Ecstasy.Molly): Added Risk of MDMA. Retrieved December 10, 2016 from https://www.drugabuse.gov/publications/drugfacts/mdma-ecstasymolly#added_risk

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