3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil.
Identifieur interne : 000395 ( Main/Exploration ); précédent : 000394; suivant : 0003963,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil.
Auteurs : Alvaro V. Jardim [Brésil] ; Dora V. Jardim [Brésil] ; Bruno Rasmussen Chaves [Brésil] ; Matheus Steglich [Brésil] ; Marcela Ot'Alora G [États-Unis] ; Michael C. Mithoefer [États-Unis] ; Dartiu X. Da Silveira [Brésil] ; Luís F. T Foli [Brésil] ; Sidarta Ribeiro [Brésil] ; Rebecca Matthews [États-Unis] ; Rick Doblin [États-Unis] ; Eduardo E. Schenberg [Brésil]Source :
- Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) [ 1809-452X ] ; 2020.
Abstract
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.
CONCLUSIONS
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.
DOI: 10.1590/1516-4446-2020-0980
PubMed: 32638920
Affiliations:
- Brésil, États-Unis
- Goiás, Rio Grande do Norte, État de São Paulo
- Campinas
- Université d'État de Campinas
Links toward previous steps (curation, corpus...)
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Jardim</name><affiliation wicri:level="2"><nlm:affiliation>Centro de Educação e Psicoterapia, Goiânia, GO, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Centro de Educação e Psicoterapia, Goiânia, GO</wicri:regionArea><placeName><region type="state">Goiás</region></placeName></affiliation></author><author><name sortKey="Jardim, Dora V" sort="Jardim, Dora V" uniqKey="Jardim D" first="Dora V" last="Jardim">Dora V. Jardim</name><affiliation wicri:level="2"><nlm:affiliation>Centro de Educação e Psicoterapia, Goiânia, GO, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Centro de Educação e Psicoterapia, Goiânia, GO</wicri:regionArea><placeName><region type="state">Goiás</region></placeName></affiliation></author><author><name sortKey="Chaves, Bruno Rasmussen" sort="Chaves, Bruno Rasmussen" uniqKey="Chaves B" first="Bruno Rasmussen" last="Chaves">Bruno Rasmussen Chaves</name><affiliation wicri:level="2"><nlm:affiliation>Instituto Phaneros, São Paulo, SP, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Instituto Phaneros, São Paulo, SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Steglich, Matheus" sort="Steglich, Matheus" uniqKey="Steglich M" first="Matheus" last="Steglich">Matheus Steglich</name><affiliation wicri:level="2"><nlm:affiliation>Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Ot Alora G, Marcela" sort="Ot Alora G, Marcela" uniqKey="Ot Alora G M" first="Marcela" last="Ot'Alora G">Marcela Ot'Alora G</name><affiliation wicri:level="1"><nlm:affiliation>Private Practice Boulder, CO, Aguazul-Bluewater, Inc, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Private Practice Boulder, CO, Aguazul-Bluewater, Inc</wicri:regionArea><wicri:noRegion>Inc</wicri:noRegion></affiliation></author><author><name sortKey="Mithoefer, Michael C" sort="Mithoefer, Michael C" uniqKey="Mithoefer M" first="Michael C" last="Mithoefer">Michael C. Mithoefer</name><affiliation wicri:level="1"><nlm:affiliation>Medical University of South Carolina, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Medical University of South Carolina</wicri:regionArea></affiliation></author><author><name sortKey="Da Silveira, Dartiu X" sort="Da Silveira, Dartiu X" uniqKey="Da Silveira D" first="Dartiu X" last="Da Silveira">Dartiu X. Da Silveira</name><affiliation wicri:level="2"><nlm:affiliation>Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="T Foli, Luis F" sort="T Foli, Luis F" uniqKey="T Foli L" first="Luís F" last="T Foli">Luís F. T Foli</name><affiliation wicri:level="4"><nlm:affiliation>Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, Universidade Estadual de Campinas (UNICAMP), Campinas, SP, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, Universidade Estadual de Campinas (UNICAMP), Campinas, SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region><settlement type="city">Campinas</settlement></placeName><orgName type="university">Université d'État de Campinas</orgName></affiliation></author><author><name sortKey="Ribeiro, Sidarta" sort="Ribeiro, Sidarta" uniqKey="Ribeiro S" first="Sidarta" last="Ribeiro">Sidarta Ribeiro</name><affiliation wicri:level="2"><nlm:affiliation>Brain Institute, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Brain Institute, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN</wicri:regionArea><placeName><region type="state">Rio Grande do Norte</region></placeName></affiliation></author><author><name sortKey="Matthews, Rebecca" sort="Matthews, Rebecca" uniqKey="Matthews R" first="Rebecca" last="Matthews">Rebecca Matthews</name><affiliation wicri:level="1"><nlm:affiliation>MAPS Public Benefit Corporation, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>MAPS Public Benefit Corporation</wicri:regionArea></affiliation></author><author><name sortKey="Doblin, Rick" sort="Doblin, Rick" uniqKey="Doblin R" first="Rick" last="Doblin">Rick Doblin</name><affiliation wicri:level="1"><nlm:affiliation>Multidisciplinary Association for Psychedelic Studies, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Multidisciplinary Association for Psychedelic Studies</wicri:regionArea></affiliation></author><author><name sortKey="Schenberg, Eduardo E" sort="Schenberg, Eduardo E" uniqKey="Schenberg E" first="Eduardo E" last="Schenberg">Eduardo E. Schenberg</name><affiliation wicri:level="2"><nlm:affiliation>Instituto Phaneros, São Paulo, SP, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Instituto Phaneros, São Paulo, SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation></author></analytic><series><title level="j">Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)</title><idno type="eISSN">1809-452X</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>CLINICAL TRIAL REGISTRATION</b></p><p>RBR-6sq4c9.</p></div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32638920</PMID><DateRevised><Year>2020</Year><Month>07</Month><Day>08</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1809-452X</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Jul</Month><Day>03</Day></PubDate></JournalIssue><Title>Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)</Title><ISOAbbreviation>Braz J Psychiatry</ISOAbbreviation></Journal><ArticleTitle>3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">S1516-44462020005020203</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1590/1516-4446-2020-0980</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="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.</AbstractText><AbstractText Label="METHODS" NlmCategory="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.</AbstractText><AbstractText Label="RESULTS" NlmCategory="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.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">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.</AbstractText><AbstractText Label="CLINICAL TRIAL REGISTRATION" NlmCategory="BACKGROUND">RBR-6sq4c9.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jardim</LastName><ForeName>Alvaro V</ForeName><Initials>AV</Initials><AffiliationInfo><Affiliation>Centro de Educação e Psicoterapia, Goiânia, GO, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jardim</LastName><ForeName>Dora V</ForeName><Initials>DV</Initials><AffiliationInfo><Affiliation>Centro de Educação e Psicoterapia, Goiânia, GO, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chaves</LastName><ForeName>Bruno Rasmussen</ForeName><Initials>BR</Initials><AffiliationInfo><Affiliation>Instituto Phaneros, São Paulo, SP, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Steglich</LastName><ForeName>Matheus</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ot'alora G</LastName><ForeName>Marcela</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Private Practice Boulder, CO, Aguazul-Bluewater, Inc, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mithoefer</LastName><ForeName>Michael C</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>Medical University of South Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>da Silveira</LastName><ForeName>Dartiu X</ForeName><Initials>DX</Initials><AffiliationInfo><Affiliation>Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tófoli</LastName><ForeName>Luís F</ForeName><Initials>LF</Initials><AffiliationInfo><Affiliation>Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, Universidade Estadual de Campinas (UNICAMP), Campinas, SP, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ribeiro</LastName><ForeName>Sidarta</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Brain Institute, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Matthews</LastName><ForeName>Rebecca</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>MAPS Public Benefit Corporation, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Doblin</LastName><ForeName>Rick</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Multidisciplinary Association for Psychedelic Studies, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schenberg</LastName><ForeName>Eduardo E</ForeName><Initials>EE</Initials><AffiliationInfo><Affiliation>Instituto Phaneros, São Paulo, SP, Brazil.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>03</Day></ArticleDate></Article><MedlineJournalInfo><Country>Brazil</Country><MedlineTA>Braz J Psychiatry</MedlineTA><NlmUniqueID>100895975</NlmUniqueID><ISSNLinking>1516-4446</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2019</Year><Month>09</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>05</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>7</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>7</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>7</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32638920</ArticleId><ArticleId IdType="pii">S1516-44462020005020203</ArticleId><ArticleId IdType="doi">10.1590/1516-4446-2020-0980</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Brésil</li><li>États-Unis</li></country><region><li>Goiás</li><li>Rio Grande do Norte</li><li>État de São Paulo</li></region><settlement><li>Campinas</li></settlement><orgName><li>Université d'État de Campinas</li></orgName></list><tree><country name="Brésil"><region name="Goiás"><name sortKey="Jardim, Alvaro V" sort="Jardim, Alvaro V" uniqKey="Jardim A" first="Alvaro V" last="Jardim">Alvaro V. Jardim</name></region><name sortKey="Chaves, Bruno Rasmussen" sort="Chaves, Bruno Rasmussen" uniqKey="Chaves B" first="Bruno Rasmussen" last="Chaves">Bruno Rasmussen Chaves</name><name sortKey="Da Silveira, Dartiu X" sort="Da Silveira, Dartiu X" uniqKey="Da Silveira D" first="Dartiu X" last="Da Silveira">Dartiu X. Da Silveira</name><name sortKey="Jardim, Dora V" sort="Jardim, Dora V" uniqKey="Jardim D" first="Dora V" last="Jardim">Dora V. Jardim</name><name sortKey="Ribeiro, Sidarta" sort="Ribeiro, Sidarta" uniqKey="Ribeiro S" first="Sidarta" last="Ribeiro">Sidarta Ribeiro</name><name sortKey="Schenberg, Eduardo E" sort="Schenberg, Eduardo E" uniqKey="Schenberg E" first="Eduardo E" last="Schenberg">Eduardo E. Schenberg</name><name sortKey="Steglich, Matheus" sort="Steglich, Matheus" uniqKey="Steglich M" first="Matheus" last="Steglich">Matheus Steglich</name><name sortKey="T Foli, Luis F" sort="T Foli, Luis F" uniqKey="T Foli L" first="Luís F" last="T Foli">Luís F. T Foli</name></country><country name="États-Unis"><noRegion><name sortKey="Ot Alora G, Marcela" sort="Ot Alora G, Marcela" uniqKey="Ot Alora G M" first="Marcela" last="Ot'Alora G">Marcela Ot'Alora G</name></noRegion><name sortKey="Doblin, Rick" sort="Doblin, Rick" uniqKey="Doblin R" first="Rick" last="Doblin">Rick Doblin</name><name sortKey="Matthews, Rebecca" sort="Matthews, Rebecca" uniqKey="Matthews R" first="Rebecca" last="Matthews">Rebecca Matthews</name><name sortKey="Mithoefer, Michael C" sort="Mithoefer, Michael C" uniqKey="Mithoefer M" first="Michael C" last="Mithoefer">Michael C. Mithoefer</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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