Abstract
RationalePosttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual’s health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD.ObjectivesTo examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD.MethodsParticipants received two to three active doses of MDMA (75–125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire.ResultsThere was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = − 44.8 (2.82), p < .0001), with a Cohen’s d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = − 5.2 (2.29), p < .05), with a Cohen’s d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation.ConclusionsPTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD.Trial registrationclinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610
Highlights
Posttraumatic stress disorder (PTSD) is a chronic mental illness that affects approximately 3% to 4% of the general population, 17% of US war veterans who served in Iraq or Afghanistan (Hoge et al 2004; Kessler et al 2004), and 32% of emergency personnel and first responders (Hoge et al 2004; Javidi and Yadollahie 2012)
The present analysis extends the follow-up of participants across six phase 2 clinical trials who had participated in a treatment protocol consisting of two or three 8-h psychotherapy sessions combined with MDMA for treatment of PTSD
To examine long-term changes in PTSD symptoms after MDMA-assisted psychotherapy, secondary treatment endpoints, and long-term follow-up data across six phase 2 trials were pooled for analysis
Summary
Posttraumatic stress disorder (PTSD) is a chronic mental illness that affects approximately 3% to 4% of the general population, 17% of US war veterans who served in Iraq or Afghanistan (Hoge et al 2004; Kessler et al 2004), and 32% of emergency personnel and first responders (Hoge et al 2004; Javidi and Yadollahie 2012). Psychotherapies for PTSD, compared to pharmacotherapies, have greater effects with more enduring benefits (Kline et al 2018; Lee et al 2016; Merz et al 2019) and typically have lower dropout rates. This is true of trauma-focused therapies, which are considered first-line treatment for PTSD, that require participants to engage with trauma-related thoughts, feelings, and responses (Lee et al 2016; Steenkamp et al 2015). Novel treatments for chronic PTSD are needed, especially among individuals who do not respond to conventional treatment
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