Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials
Autor: | Berra Yazar-Klosinski, Rick Doblin, Julie B. Wang, Amy Emerson, Lisa Jerome, Scott Hamilton, Michael C. Mithoefer, Allison A. Feduccia |
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Rok vydání: | 2020 |
Předmět: |
Adult
Male Chronic condition MDMA Psychotherapist Long term follow up N-Methyl-3 4-methylenedioxyamphetamine MDMA-assisted psychotherapy Pharmacology toxicology Stress Disorders Post-Traumatic 03 medical and health sciences 0302 clinical medicine Double-Blind Method Surveys and Questionnaires mental disorders Humans Medicine Longitudinal Studies Long-term follow-up Original Investigation Pharmacology Cross-Over Studies Dose-Response Relationship Drug business.industry PTSD Middle Aged Combined Modality Therapy 030227 psychiatry Psychotherapy Posttraumatic stress Treatment Outcome Pooled analysis Symptom improvement Mental health care Female business 030217 neurology & neurosurgery Follow-Up Studies medicine.drug |
Zdroj: | Psychopharmacology |
ISSN: | 1432-2072 0033-3158 |
Popis: | Rationale Posttraumatic 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. Objectives To examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD. Methods Participants 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. Results There was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = − 44.8 (2.82), p 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 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. Conclusions PTSD 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 registration clinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610 |
Databáze: | OpenAIRE |
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