PMID- 32638920
OWN - NLM
STAT- MEDLINE
DCOM- 20210426
LR  - 20210426
IS  - 1809-452X (Electronic)
IS  - 1516-4446 (Print)
IS  - 1516-4446 (Linking)
VI  - 43
IP  - 2
DP  - 2021 Mar-Apr
TI  - 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of 
      sexual abuse with severe post-traumatic stress disorder: an open label pilot 
      study in Brazil.
PG  - 181-185
LID - 10.1590/1516-4446-2020-0980 [doi]
AB  - 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.
FAU - Jardim, Alvaro V
AU  - Jardim AV
AD  - Centro de Educacao e Psicoterapia, Goiania, GO, Brazil.
FAU - Jardim, Dora V
AU  - Jardim DV
AD  - Centro de Educacao e Psicoterapia, Goiania, GO, Brazil.
FAU - Chaves, Bruno Rasmussen
AU  - Chaves BR
AD  - Instituto Phaneros, Sao Paulo, SP, Brazil.
FAU - Steglich, Matheus
AU  - Steglich M
AD  - Departamento de Psiquiatria, Universidade Federal de Sao Paulo (UNIFESP), Sao 
      Paulo, SP, Brazil.
FAU - Ot'alora G, Marcela
AU  - Ot'alora G M
AD  - Private Practice Boulder, CO, Aguazul-Bluewater, Inc, USA.
FAU - Mithoefer, Michael C
AU  - Mithoefer MC
AD  - Medical University of South Carolina, USA.
FAU - da Silveira, Dartiu X
AU  - da Silveira DX
AD  - Departamento de Psiquiatria, Universidade Federal de Sao Paulo (UNIFESP), Sao 
      Paulo, SP, Brazil.
FAU - Tofoli, Luis F
AU  - Tofoli LF
AUID- ORCID: 0000-0003-2262-8272
AD  - Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School 
      of Medical Sciences, Universidade Estadual de Campinas (UNICAMP), Campinas, SP, 
      Brazil.
FAU - Ribeiro, Sidarta
AU  - Ribeiro S
AD  - Brain Institute, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, 
      Brazil.
FAU - Matthews, Rebecca
AU  - Matthews R
AD  - MAPS Public Benefit Corporation, USA.
FAU - Doblin, Rick
AU  - Doblin R
AD  - Multidisciplinary Association for Psychedelic Studies, USA.
FAU - Schenberg, Eduardo E
AU  - Schenberg EE
AUID- ORCID: 0000-0001-7111-9891
AD  - Instituto Phaneros, Sao Paulo, SP, Brazil.
LA  - eng
PT  - Journal Article
PL  - Brazil
TA  - Braz J Psychiatry
JT  - Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)
JID - 100895975
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Brazil
MH  - Humans
MH  - *N-Methyl-3,4-methylenedioxyamphetamine
MH  - Pilot Projects
MH  - Psychotherapy
MH  - *Sex Offenses
MH  - *Stress Disorders, Post-Traumatic/drug therapy
MH  - Treatment Outcome
PMC - PMC8023155
COIS- The authors report no conflicts of interest.
EDAT- 2020/07/09 06:00
MHDA- 2021/04/27 06:00
PMCR- 2020/07/03
CRDT- 2020/07/09 06:00
PHST- 2019/09/05 00:00 [received]
PHST- 2020/05/21 00:00 [accepted]
PHST- 2020/07/09 06:00 [pubmed]
PHST- 2021/04/27 06:00 [medline]
PHST- 2020/07/09 06:00 [entrez]
PHST- 2020/07/03 00:00 [pmc-release]
AID - S1516-44462020005020203 [pii]
AID - 10.1590/1516-4446-2020-0980 [doi]
PST - ppublish
SO  - Braz J Psychiatry. 2021 Mar-Apr;43(2):181-185. doi: 10.1590/1516-4446-2020-0980.