3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.

Autor:	Ot'alora G M; 1 Aguazul-Bluewater, Inc., Boulder, CO, USA., Grigsby J; 2 Department of Psychology, University of Colorado, Denver, CO, USA., Poulter B; 1 Aguazul-Bluewater, Inc., Boulder, CO, USA., Van Derveer JW 3rd; 3 Integrative Psychiatric Healing Center, Boulder, CO, USA., Giron SG; 4 Multidisciplinary Association for Psychedelic Studies (MAPS), Boulder, USA., Jerome L; 5 MAPS Public Benefit Corporation, Boulder, CO, USA., Feduccia AA; 5 MAPS Public Benefit Corporation, Boulder, CO, USA., Hamilton S; 6 Stanford School of Medicine, Stanford, CA, USA., Yazar-Klosinski B; 4 Multidisciplinary Association for Psychedelic Studies (MAPS), Boulder, USA., Emerson A; 5 MAPS Public Benefit Corporation, Boulder, CO, USA., Mithoefer MC; 7 Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA., Doblin R; 4 Multidisciplinary Association for Psychedelic Studies (MAPS), Boulder, USA.
Jazyk:	angličtina
Zdroj:	Journal of psychopharmacology (Oxford, England) [J Psychopharmacol] 2018 Dec; Vol. 32 (12), pp. 1295-1307. Date of Electronic Publication: 2018 Oct 29.
DOI:	10.1177/0269881118806297
Abstrakt:	Background: Posttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms. Aims: This pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams. Methods: Twenty-eight people with chronic posttraumatic stress disorder were randomized in a double-blind dose response comparison of two active doses (100 and 125 mg) with a low dose (40 mg) of MDMA administered during eight-hour psychotherapy sessions. Change in the Clinician-Administered PTSD Scale total scores one month after two sessions of MDMA served as the primary outcome. Active dose groups had one additional open-label session; the low dose group crossed over for three open-label active dose sessions. A 12-month follow-up assessment occurred after the final MDMA session. Results: In the intent-to-treat set, the active groups had the largest reduction in Clinician-Administered PTSD Scale total scores at the primary endpoint, with mean (standard deviation) changes of -26.3 (29.5) for 125 mg, -24.4 (24.2) for 100 mg, and -11.5 (21.2) for 40 mg, though statistical significance was reached only in the per protocol set ( p=0.03). Posttraumatic stress disorder symptoms remained lower than baseline at 12-month follow-up ( p<0.001) with 76% ( n=25) not meeting posttraumatic stress disorder criteria. There were no drug-related serious adverse events, and the treatment was well-tolerated. Conclusions: Our findings support previous investigations of MDMA-assisted psychotherapy as an innovative, efficacious treatment for posttraumatic stress disorder.
Databáze:	MEDLINE
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