Projeto de Parceria IP – MAPS

Study Project of Assisted Psychotherapy with 3,4-methylenedioxy-Nmethylamphetamine (MDMA) in the treatment of post-traumatic stress disorder.

Sponsor:
Instituto Phaneros, São Paulo, SP, Brasil

Main Investigator:
Dr. Eduardo Ekman Schenberg, UNIFESP/Instituto Phaneros

Associate Investigator 1:
Prof. Dr. Luís Fernando Tófoli, UNICAMP/Instituto Phaneros

Associate Investigator 2:
Prof. Dr. Dartiu Xavier da Silveira, UNIFESP/Instituto Phaneros

Associate Investigator 3:
Prof. Dr. Sidarta Ribeiro, UFRN/Instituto Phaneros

Therapist 1:
Alvaro da Veiga Jardim, Centro de Educação e Psicoterapia

Therapist 2:
Dora da Veiga Jardim, Centro de Educação e Psicoterapia

Doctor responsible:
Dr. Bruno Daniel Rasmussen Chaves

Treatment venue:
Centro de Educação e Psicoterapia, Rua 115, 1764 – Setor Sul, CEP 74085-240 – Goiânia – GO

 

Abstract

This is an open Phase 2 clinical trial with patients with Post-Traumatic Stress Disorder (PTSD) to adapt the therapeutic model developed in the USA and approved by the Food and Drug Administration (FDA) to the Brazilian context. The study will include four patients diagnosed at least 6 months ago and who have not responded to currently available PTSD treatments. Patients eligible and accepted for the study will undergo three sessions combining psychotherapy with ingestion of 3,4-methylenedioxy-N-methylamphetamine (MDMA). Each therapeutic session will last approximately six to eight hours, being separated by two to four weeks. The first therapeutic session will be preceded by a preparatory psychotherapy phase including three 90-minute sessions. Each MDMA therapeutic session will be followed by an integrative psychotherapy phase without medication, including three 90-minute sessions. All treatment will be conducted by a pair of co-therapists, being a male therapist and a female therapist, who will be present throughout the duration of the medication. All patients will undergo long-term follow-up 12 months after the last therapeutic session in which data will be obtained for the final evaluation of the treatment result.

At each session, the volunteer will receive an initial dose of MDMA that can be added to a supplementary dose equivalent to 50% of the initial dose after 90 to 120 minutes. In the first therapeutic session, volunteers will receive 75 mg of MDMA, and in the second and third sessions, volunteers will receive 75 or 125 mg of MDMA. The decision on whether to use the 75 or 125 mg dose, as well as to supplement the half dose, will be made by the Responsible Physician and by the therapists according to the volunteer's experience in the previous sessions. The study outcome will occur sixty days after the third MDMA therapy session. There will be a long-term follow-up, to be carried out approximately 12 months after the last therapeutic session.

The main objective of this study is to evaluate the validity of the model established in the USA within the Brazilian context. For this, changes in PTSD symptoms will be measured by comparing the global PTSD symptom severity indices according to the Clinician-Administered PTSD Scale (CAPS) at the beginning of the study, 60 days after the third MDMA therapy session and, finally, in a long-term follow-up 12 months after the last therapeutic session with the drug. Additional assessments (in addition to CAPS) will include self-reported PTSD symptoms (PCL-C), depression (BDI-II), psychological function (GAF), sleep quality (PSQI), post-traumatic growth (PTGI) and dissociation (DES-II ) in volunteers with PTSD. Secondary objectives include training therapists with this specific treatment modality combining pharmacology with psychotherapy already underway in countries such as Israel, Switzerland, Canada and the USA. In addition, this study will allow the preparation of a team for a possible Phase 3 Clinical Trial in Brazil, following an international multicenter project scheduled to start in the USA, Israel, Canada, Switzerland and England from 2017. This Phase 3 Clinical trial will be sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization founded in the USA.

• Manual for MDMA Assisted Psychotherapy in the Treatment of Post-Traumatic Stress Disorder - By Michael Mithoeffer, M.D.
• 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil – by Alvaro V. Jardim, Dora V. Jardim, Bruno Rasmussen Chaves, Matheus Steglich, Marcela Ot’alora G., Michael C. Mithoefer, Dartiu X. da Silveira, Luís F. Tófoli, Sidarta Ribeiro, Rebecca Matthews, Rick Doblin, Eduardo E. Schenberg.

 

Some Articles of Interest:

• MDMA-Assisted Psychotherapy: How Different is it from Other Psychotherapy? – By Michael Mithoeffer, M.D.
• Research Update: MDMA-Assisted Psychotherapy for PTSD – by Michael Mithoeffer, M.D.
• Ethical caring in psychedelic work – By Kylea Taylor, M.S.
• 3,4-Methylenedioxymethamphetamineassisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial – Marcela Ot’alora G 1, Jim Grigsby 2, Bruce Poulter 1, Joseph W Van Derveer III 3, Sara Gael Giron 4, Lisa Jerome 5, Allison A Feduccia 5, Scott Hamilton 6, Berra Yazar-Klosinski 4, Amy Emerson 5, Michael C Mithoefer 7 and Rick Doblin 4
• Psychedelic drugs as new tools in psychiatric therapeutics – By Eduardo E. Schenberg
• Treating drug dependence with the aid of ibogaine: A retrospective study – By Eduardo Eckman Schenberg, Maria Angélica de Castro Comis, Bruno Rasmussen Chaves, Dartiu Xavier da Silveira
• Treating drug dependence with the aid of ibogaine: A qualitative study – By Eduardo Eckman Schenberg, Maria Angélica de Castro Comis, João Felipe Morel Alexandre, Bruno Daniel Rasmussen Chaves, Luís Fernando Tófoli, and Dartiu Xavier da Silveira.