A drug often known as “Ecstasy” or “Molly,” has for decades been used as a party drug in clubs and for all-night raves. But lately, ±3, 4-methylenedioxymethamphetamine (MDMD) is also being used in very different settings and for a very different purpose. Pharmacologically, MDMA acts as a serotonin-norepinephrine-dopamine releasing agent and reuptake inhibitor. Basically, MDMA massively increases the release of serotonin, dopamine, and oxytocin. Respectively, these chemicals in the brain help you feel relaxed and calm, help you stay alert, and help you bond with people and be more trusting. Increased feelings of trust and compassion towards others would allow people to process their trauma, which could make an ideal adjunct to psychotherapy for PTSD.
The Food and Drug Administration (FDA) has approved phase two clinical studies of the treatment, and they are now underway in four separate locations in South Carolina, Colorado, Canada, and Israel. Results so far have been promising. Preliminary studies have shown that MDMA in conjunction with psychotherapy can help people overcome PTSD and possibly other disorders as well. MDMA is not the same as “Ecstasy” or “Molly.” Substances sold on the street under these names may contain MDMA, but frequently also contain unknown and/or dangerous adulterants. In laboratory studies, pure MDMA has been proven sufficiently safe for human consumption when taken a limited number of times in moderate doses. In MDMA-assisted psychotherapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for years, and sometimes over the course of a lifetime.
Recent test results have shown 83 percent of the subjects receiving MDMA-assisted psychotherapy in a pilot study no longer met the criteria for PTSD, and every patient who received a placebo and then went on to receive MDMA-assisted psychotherapy experienced significant and lasting improvements. Long-term follow-up of patients who received MDMA-assisted psychotherapy revealed that overall benefits were maintained an average of 3.8 years later. These results indicate a promising future for MDMA-assisted psychotherapy for PTSD and lay the groundwork for continued research into the safest and most effective ways to administer the treatment.
The Multidisciplinary Association for Psychedelic Studies (MAPS) is undertaking a roughly $20 million plan to make MDMA into a FDA approved prescription medicine by 2021, and is currently the only organization in the world funding clinical trials of MDMA-assisted psychotherapy. For-profit pharmaceutical companies are not interested in developing MDMA into a medicine because the patent for MDMA has expired. Data from Phase 2 studies will be used to plan Phase 3of MAPS’ drug development program. MAPS will work with the FDA to agree on a design for Phase 3 studies and submit the findings to the FDA in a New Drug Application (NDA) to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD. Phase 3 of the development program will involve scores of therapists and hundreds of subjects in multiple countries and large multi-center trials. The challenge is no longer convincing regulatory agencies of the value of this research, but finding the financial resources for conducting the Phase 3 studies required to make MDMA-assisted psychotherapy a legally available treatment for those who need it most.
References:
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(4), 439-452.
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, 0 (0), 1-12. DOI: 10.1177/0269881112456611
Oehen, P., Traber, R., Widmer, V., & Schnyder, U. (2012). A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)- assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). Journal of Psychopharmacology, 0, 1-13. DOI: 10.1177/0269881112464827
Jonathan Torres, M.S.
WKPIC Doctoral Intern