Abstract

Over the past 15 years, funding and implementation of research projects exploring the range of effects and therapeutic potential of psychedelic drugs have notably increased. This presentation will examine the rationale, methodology, and findings of 2 recent areas of research attention, the use of a psilocybin treatment model for existential anxiety reactive to advanced cancer and the use of an MDMA (3,4-methylenedioxy-methamphetamine) treatment model for social anxiety in adults with autism spectrum disorder. Double-blind, placebo-controlled methodologies were utilized in both studies. The psilocybin study utilized a within-subject control design, with each subject administered 2 blinded treatment sessions, one with the experimental drug and the other with the placebo control. The MDMA study randomized subjects into either the experimental drug group or the placebo group, administering 2 treatment sessions to all subjects. Following the 6-month data-collection follow-up period, the blind was broken and 2 open-label MDMA sessions were offered to each of the subjects who had been randomized to the placebo group. The psilocybin and MDMA studies each established feasibility as well as effective safety parameters. With the psilocybin investigation, statistically significant reductions in anxiety were identified at various points over the 6-month follow-up period, along with a notable reduction in depression scores at the 6-month data point. The MDMA study demonstrated a drug effect size of 1.4 for reduction of social anxiety. Both the psilocybin and MDMA studies demonstrated trends toward therapeutic efficacy, with amelioration of identified target symptoms. Each of these pilot investigations succeeded in obtaining all necessary regulatory approvals, requisite funding, and outcome measures consistent with therapeutic outcome. Both studies support further clinical explorations of the treatment potential of these novel psychoactive compounds.

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