Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychothera
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ORIGINAL INVESTIGATION
Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychotherapy Allison A. Feduccia 1
&
Lisa Jerome 2 & Michael C. Mithoefer 2,3 & Julie Holland 4
Received: 27 April 2020 / Accepted: 10 November 2020 # The Author(s) 2020
Abstract Rationale MDMA-assisted psychotherapy is under investigation as a novel treatment for posttraumatic stress disorder (PTSD). The primary mechanism of action of MDMA involves the same reuptake transporters targeted by antidepressant medications commonly prescribed for PTSD. Objectives Data were pooled from four phase 2 trials of MDMA-assisted psychotherapy. To explore the effect of tapering antidepressant medications, participants who had been randomized to receive active doses of MDMA (75–125 mg) were divided into two groups (taper group (n = 16) or non-taper group (n = 34)). Methods Between-group comparisons were made for PTSD and depression symptom severity at the baseline and the primary endpoint, and for peak vital signs across two MDMA sessions. Results Demographics, baseline PTSD, and depression severity were similar between the taper and non-taper groups. At the primary endpoint, the non-taper group (mean = 45.7, SD = 27.17) had a significantly (p = 0.009) lower CAPS-IV total scores compared to the taper group (mean = 70.3, SD = 33.60). More participants in the non-taper group (63.6%) no longer met PTSD criteria at the primary endpoint than those in the taper group (25.0%). The non-taper group (mean = 12.7, SD = 10.17) had lower depression symptom severity scores (p = 0.010) compared to the taper group (mean = 22.6, SD = 16.69). There were significant differences between groups in peak systolic blood pressure (p = 0.043) and diastolic blood pressure (p = 0.032). Conclusions Recent exposure to antidepressant drugs that target reuptake transporters may reduce treatment response to MDMAassisted psychotherapy. Keywords MDMA . MDMA-assisted psychotherapy . SSRI . SNRI . Taper . Discontinuation syndrome . Psychedelics . PTSD
Introduction PTSD is a relatively prevalent disorder, affecting 3 to 4% of the global population (Hoge et al. 2004; Koenen et al. 2017). People with PTSD can face reduced quality of life in multiple areas, from workplace productivity to interpersonal relationships, and are at increased risk for suicidal thoughts or behavior (Sareen et al. 2007; Shea et al. 2010). Currently available treatments include pharmacotherapies and psychotherapies. Two selective * Allison A. Feduccia [email protected] 1
Psychedelic.Support, Project New Day, Santa Cruz, CA, USA
2
MAPS Public Benefit Corporation, Santa Cruz, CA, USA
3
Medical University of South Carolina, Charleston, SC, USA
4
Private Practice, New York, NY, USA
serotonin reuptake inhibitors (SSRI), sertraline and paroxetine, are the only FDA-approved medications for PTSD, but other adjunctive drugs are also commonly prescribed for sleep disturbances and anxiety associated with PTSD. Six phase 2 randomized, double-blind placebo-contr
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