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

Abstract Background The States of Consciousness Questionnaire (SOCQ) was developed to assess the occurrence features of the change in consciousness induced by psilocybin, and includes the Mystical Experience Questionnaire (MEQ), developed to assess the ocurrence of mystical experiences in altered states of consciousness. Objective To translate the SOCQ to Brazilian Portuguese and validate the 30-item MEQ. Methods The SOCQ was translated to Brazilian Portuguese and backtranslated into English. The two English versions were compared and differences corrected, resulting in a Brazilian translation. Using an internet-survey, 1504 Portuguese-speaking subjects answered the translated version of the SOCQ. The 4-factor version of MEQ30 was analyzed using confirmatory factor analysis and reliability analysis. Results A Brazilian Portuguese version of the SOCQ was made available. Goodness-of-fit indexes indicated that data met the factorial structure proposed for the English MEQ30. Factors presented excellent to acceptable reliability according to Cronbach’s alpha: mystical (0.95); positive mood (0.71); transcendence of time/space (0.83); and ineffability (0.81). Discussion The Brazilian Portuguese version of the MEQ30 is validated and it fits in the factorial structure performed on the original English version. The SOCQ is also available to the Brazilian Portuguese speaking population, allowing studies in different languages to be conducted and compared systematically.