Originally appeared at: http://www.treatmentsolutionsnetwork.com/blog/index.php/2010/08/02/using-ecstasy-to-treat-ptsd/ Action Points • Explain to interested patients that the drug MDMA (commonly called Ecstasy) is not legally available in the U.S. outside of a clinical trial setting. • Point out that MDMA was used in a strictly controlled setting with intensive support from therapists before, during, and after use of the drug during psychotherapy sessions. Patients with refractory post-traumatic stress disorder got relief from the illegal drug known as Ecstasy, ±3,4-methylenedioxymethamphetamine (MDMA), according to a small pilot study. The phase II study, involving just 20 patients, showed that when used during intensive psychotherapy, MDMA resulted in greater reductions in PTSD symptoms over time than placebo (P=0.015), said Michael Mithoefer, MD, a psychiatrist in private practice in Mount Pleasant, S.C., and colleagues. The percentage of patients who had at least a 30% reduction in PTSD score — a drop considered clinically meaningful — was greater in the MDMA group compared with the placebo group (83.3% versus 25%), Mithoefer and colleagues reported online in theJournal of Psychopharmacology. Similar proportions of patients no longer met criteria for PTSD at the end of the study. These preliminary findings indicate the need to do further research on MDMA as an adjunct to psychotherapy, Mithoefer told MedPage Today. “We’ve got a long way to go,” acknowledged Mithoefer, who speculated that it might take another 10 years before such a treatment is approved. In the meantime, he expressed concern that publicity about the study might lead some people to self-medicate with Ecstasy. PTSD patients should not use the drug on their own, Mithoefer said, because there are risks, such as elevated blood pressure and pulse. Also, Ecstasy purchased on the street may not be pure MDMA — or even contain no MDMA at all. Most importantly, however, the current study was conducted under strictly controlled conditions with ample support from therapists before, during, and after the sessions, he stressed. “The MDMA was not a ‘magic bullet’ that removed their PTSD,” Mithoefer explained. “It seemed to act as a catalyst to therapy, and, as in any therapy for PTSD, the therapeutic process was often challenging.” Using MDMA in this manner is not a new idea. Case reports show that psychiatrists in the U.S. and Europe were using the drug as an adjunct to psychotherapy before it was criminalized in 1985. But the current study is the first completed clinical trial evaluating the treatment. After receiving approval from the FDA and the Drug Enforcement Administration, Mithoefer and his colleagues recruited 20 patients with PTSD (mean age 40; 85% female). All but one of the patients had PTSD resulting from crimes, mostly childhood physical or sexual abuse or rape. The average duration of PTSD among the study group was about 20 years, and previous psychotherapy or drug treatment had failed. All patients received intensive psychotherapy during two eight-hours sessions followed by an overnight stay. Researchers provided non-drug-assisted sessions before and after the drug- or placebo-assisted sessions. Twelve patients were randomized to pure MDMA (125 mg initially with an optional supplemental dose of 62.5 mg) during their experimental sessions and eight patients were assigned to placebo. A blinded interpreter applied the Clinician-Administered PTSD Scale (CAPS) at baseline, four days after each drug-assisted psychotherapy session and two months after the second session. During the sessions, blood pressure, pulse, and body temperature increased in the MDMA group (P<0.05), although all values returned to baseline levels by the end of the sessions. There were no major medical complications or serious drug-related adverse events. The CAPS score improved in both groups, although there was a significantly larger improvement in the MDMA group at each time point. At the end of the two-month study period, the placebo group was allowed to begin open-label treatment with MDMA. Seven of the eight control patients participated, and there was a significant decrease in CAPS score similar to that seen in the initial MDMA group (P<0.05). There were no between-group differences on neurocognitive tests during the study. Mithoefer said the reason MDMA appears to act as a catalyst for psychotherapy is unclear. But he speculates that it allows patients to remain engaged with therapy without experiencing the extremes of the overwhelming anxiety or emotional numbing inherent in PTSD when reliving trauma. The pharmacological effects of MDMA include serotonin release, 5HT2 receptor stimulation, and increases in the levels of oxytocin, prolactin, and cortisol, according to background information provided by the authors. Mithoefer and colleagues acknowledged some limitations of the study, including its small sample size, the inclusion of mostly female and all-white patients, the apparent ineffectiveness of the blinding, the possibility that the results were influenced by the placebo effect, the absence of therapist adherence measures, and the short follow-up period. In addition, patients assigned to placebo had a history of more psychotherapy at baseline, possibly indicating that they were more treatment resistant, and patients in the MDMA group had more psychotherapy sessions after their drug-assisted sessions. The study was funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), which employs two of the study authors. Mithoefer is medical monitor for other studies of MDMA-assisted psychotherapy currently being conducted by MAPS. He and co-author Ann Mithoefer both receive payment from MAPS for conducting this research and working on development of a treatment manual, investigator training program, and protocols for additional studies planned by MAPS. Primary source: Journal of Psychopharmacology Source reference: Mithoefer M, et al “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” J Psychopharmacol 2010; DOI: 10.1177/0269881110378371.
The author of this article prefaces it with two action points: “Explain to interested patients that the drug MDMA (commonly called Ecstasy) is not legally available in the U.S. outside of a clinical trial setting.” and “Point out that MDMA was used in a strictly controlled setting with intensive support from therapists before, during, and after use of the drug during psychotherapy sessions”.
