Previous Clinical Experience with MDMA Sample Clauses

Previous Clinical Experience with MDMA. Classification as a Schedule 1 drug hampered research into the medical uses of MDMA. In recent years, clinical investigation of the safety and effectiveness of MDMA-assisted psychotherapy has become more feasible due to an open IND with the FDA[59-61]. The first double-blind, placebo controlled U.S. Phase 1 study sanctioned by the FDA was conducted in 1994, with findings that suggested MDMA caused a significant increase in body temperature and heart rate in some healthy volunteers [62]. However, these increases were found to be transient and generally tolerable in a controlled clinical setting [62]. Subsequent trials confirmed that MDMA produced significant increases in heart rate and blood pressure that were likely to be well tolerated by healthy individuals [62-68]. The noted elevation in body temperature was not clinically significant [1]. The potentially therapeutic effects of MDMA were initially investigated starting in 2000 in a MAPS-sponsored dose-response pilot study in Spain in women survivors of sexual assault with treatment-resistant PTSD [69, 70]. Unfortunately, the study in Spain was halted in 2002 due to political pressure from the Madrid Anti-Drug Authority. Prior to its suspension, six women were enrolled and treated in this study without any adverse events (AEs) or signs of deteriorating mental health, and with some mild signs of improvement, with single doses ranging from 50 to 75 mg [70]. MAPS went on to sponsor the first U.S. Phase 2 study of MDMA-assisted psychotherapy for the treatment of chronic, treatment resistant PTSD, designated as MP-1. This study employed the CAPS as a primary outcome measure, with PTSD symptoms measured by a blinded Independent Rater (IR) at baseline, 3 to 5 days after each experimental session, and two months after the final experimental session. Data from this randomized, placebo- controlled pilot study suggests that MDMA is associated with significantly greater improvement in PTSD than placebo (N=20) [71]. Findings from the long-term follow-up evaluating these subjects at an average of 41 months post-treatment suggests that the therapeutic benefits have been sustained over time on average, although two subjects experienced a relapse in PTSD symptoms [2]. The sponsor also supported a randomized, double-blind pilot study in 12 subjects with chronic, treatment-resistant PTSD in Switzerland with 3 experimental sessions. The study results suggested a trend toward significant improvement in subjects receiving ful...
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