MAY 2011
to recognize these challenges as a meaningful part of healing. The fact that this close follow-up was necessary to address psychological difficulties underscores the potential problems that may be associated with MDMA in recreational settings. In illicit settings, in addition to these psychological risks, the primary acute risks of ecstasy (which may contain varying amounts of MDMA and other substances) involve hyperthermia and dehydration or overhydration, with resulting water intoxication and cerebral edema. These complications are highly unlikely in a controlled research setting. MDMA predictably causes increases in pulse rate and blood pressure that could be dangerous for persons with underlying cardiovascular disease. We excluded patients with any serious medical problems and psychiatric problems such as psychosis, bipolar disorder type 1, and active addiction, and we did not encounter any drug-related serious adverse events. Some controversy remains about adverse long-term neurocognitive effects in ecstasy users. Following their meta-analysis of cognitive functions of ecstasy users, Rogers and colleagues46 cautiously concluded that the drug may significantly affect verbal memory, with a lesser effect on visual memory. However, results from other meta-analyses were somewhat contradictory.47,48 A definitive conclusion about the adverse effects of MDMA remains elusive because of the considerable methodological challenges involved in studying illicit drug users; however, a very recent study by Halpern and colleagues49 that was designed to minimize these methodological problems “found little evidence of decreased cognitive performance in ecstasy users save for poorer strategic self-regulation, possibly reflecting impulsivity . . . which may have been a pre-morbid attribute of ecstasy users.” More germane to an assessment of the risks of clinical administration is the fact that there has been no evidence of memory loss or other adverse neuropsychological effects after administration of a few doses of pure MDMA in medical settings in phase 1 or phase 2 studies. In our 20 participants, we measured neurocognitive function before and after 2 doses of MDMA or 2 doses of placebo and found no indication of adverse effects.16 This is represented by the Repeatable Battery for the Assessment of Neuropsycholog-
CLINICAL PSYCHOPHARMACOLOGY ical Status (RBANS) scores shown in Figure 2. It is important to point out that our safety data should not be taken to imply that there are no psychological and physical risks accompanying the use of ecstasy, or even pure MDMA in other settings, at higher and more frequent doses, and when used in an addictive pattern,
which can be highly problematic. Like many of the drugs we use in medicine, MDMA can be dangerous when it is used inappropriately or when it is abused.
The future of MDMA in psychiatry These early results provide encouragement that MDMA-assisted psy-
PSYCHIATRIC TIMES
chotherapy may prove to be a valuable treatment for PTSD. However, there is still a long way to go from promising phase 2 trials to the demonstration of safety and efficacy in much larger phase 3 studies, which would be required for FDA approval of MDMA as a prescription medicine. (Please see MDMA, page 49)
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