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3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil
OBJECTIVE: To conduct Brazil’s first clinical trial employing 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), given its high prevalence resulting from epidemic violence. METHODS: Of 60 volunteers, four matched the inclusion & exclusion c...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Associação Brasileira de Psiquiatria
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023155/ https://www.ncbi.nlm.nih.gov/pubmed/32638920 http://dx.doi.org/10.1590/1516-4446-2020-0980 |
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author | Jardim, Alvaro V. Jardim, Dora V. Chaves, Bruno Rasmussen Steglich, Matheus Ot’alora G., Marcela Mithoefer, Michael C. da Silveira, Dartiu X. Tófoli, Luís F. Ribeiro, Sidarta Matthews, Rebecca Doblin, Rick Schenberg, Eduardo E. |
author_facet | Jardim, Alvaro V. Jardim, Dora V. Chaves, Bruno Rasmussen Steglich, Matheus Ot’alora G., Marcela Mithoefer, Michael C. da Silveira, Dartiu X. Tófoli, Luís F. Ribeiro, Sidarta Matthews, Rebecca Doblin, Rick Schenberg, Eduardo E. |
author_sort | Jardim, Alvaro V. |
collection | PubMed |
description | OBJECTIVE: To conduct Brazil’s first clinical trial employing 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), given its high prevalence resulting from epidemic violence. METHODS: Of 60 volunteers, four matched the inclusion & exclusion criteria. Three patients with PTSD secondary to sexual abuse (diagnosed by the Structured Clinical Interview for DSM-IV and the Clinician Administered PTSD Scale for DSMV-4 [CAPS 4]) completed enrollment and treatment, following a standardized Multidisciplinary Association for Psychedelic Studies protocol consisting of 15 weekly therapy sessions: three with orally administered MDMA with concurrent psychotherapy and music, spaced approximately 1 month apart. CAPS-4 scores two months after the final MDMA session were the primary outcome. RESULTS: No serious adverse events occurred. The most frequent adverse events were somatic pains and anguish. CAPS-4 reductions were always greater than 25 points. The final scores were 61, 27, and 8, down from baseline scores of 90, 78, and 72, respectively. All reductions were greater than 30%, which is indicative of clinically significant improvement. Secondary outcomes included lower Beck Depressive Inventory scores and higher Post-Traumatic Growth Inventory and Global Assessment of Functioning scores. CONCLUSION: Considering the current limitations in safe and efficacious treatments for PTSD and recent studies abroad with larger patient samples, MDMA-assisted psychotherapy could become a viable treatment in Brazil. CLINICAL TRIAL REGISTRATION: RBR-6sq4c9 |
format | Online Article Text |
id | pubmed-8023155 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Associação Brasileira de Psiquiatria |
record_format | MEDLINE/PubMed |
spelling | pubmed-80231552021-04-07 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil Jardim, Alvaro V. Jardim, Dora V. Chaves, Bruno Rasmussen Steglich, Matheus Ot’alora G., Marcela Mithoefer, Michael C. da Silveira, Dartiu X. Tófoli, Luís F. Ribeiro, Sidarta Matthews, Rebecca Doblin, Rick Schenberg, Eduardo E. Braz J Psychiatry Brief Communication OBJECTIVE: To conduct Brazil’s first clinical trial employing 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), given its high prevalence resulting from epidemic violence. METHODS: Of 60 volunteers, four matched the inclusion & exclusion criteria. Three patients with PTSD secondary to sexual abuse (diagnosed by the Structured Clinical Interview for DSM-IV and the Clinician Administered PTSD Scale for DSMV-4 [CAPS 4]) completed enrollment and treatment, following a standardized Multidisciplinary Association for Psychedelic Studies protocol consisting of 15 weekly therapy sessions: three with orally administered MDMA with concurrent psychotherapy and music, spaced approximately 1 month apart. CAPS-4 scores two months after the final MDMA session were the primary outcome. RESULTS: No serious adverse events occurred. The most frequent adverse events were somatic pains and anguish. CAPS-4 reductions were always greater than 25 points. The final scores were 61, 27, and 8, down from baseline scores of 90, 78, and 72, respectively. All reductions were greater than 30%, which is indicative of clinically significant improvement. Secondary outcomes included lower Beck Depressive Inventory scores and higher Post-Traumatic Growth Inventory and Global Assessment of Functioning scores. CONCLUSION: Considering the current limitations in safe and efficacious treatments for PTSD and recent studies abroad with larger patient samples, MDMA-assisted psychotherapy could become a viable treatment in Brazil. CLINICAL TRIAL REGISTRATION: RBR-6sq4c9 Associação Brasileira de Psiquiatria 2020-07-03 /pmc/articles/PMC8023155/ /pubmed/32638920 http://dx.doi.org/10.1590/1516-4446-2020-0980 Text en http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Brief Communication Jardim, Alvaro V. Jardim, Dora V. Chaves, Bruno Rasmussen Steglich, Matheus Ot’alora G., Marcela Mithoefer, Michael C. da Silveira, Dartiu X. Tófoli, Luís F. Ribeiro, Sidarta Matthews, Rebecca Doblin, Rick Schenberg, Eduardo E. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil |
title | 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil |
title_full | 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil |
title_fullStr | 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil |
title_full_unstemmed | 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil |
title_short | 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil |
title_sort | 3,4-methylenedioxymethamphetamine (mdma)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in brazil |
topic | Brief Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023155/ https://www.ncbi.nlm.nih.gov/pubmed/32638920 http://dx.doi.org/10.1590/1516-4446-2020-0980 |
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