X

Mdma Clinical Trials

Phase 1/2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)

To see complete record on clinicaltrials.gov, please visit this link

Id: NCT02876172

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Completed

Start Date: October 2016

Last Update: July 2, 2019

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: This small study will look at the safety and estimate the strength of effect (effect size) of a combination of Cognitive Behavioral Conjoint Therapy (CBCT) and 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in ten pairs of people, one with and one without PTSD. The pairs can be spouses or romantic partners, siblings or other relatives or close friends. The study will measure PTSD symptoms, as well as symptoms of depression, sleep quality and relationship satisfaction and functioning before and after a one-month course of CBCT that includes two MDMA+CBCT visits. CBCT psychotherapy is designed to treat PTSD and relationship problems in pairs in a close relationship, and MDMA-assisted psychotherapy uses the experimental drug MDMA to enhance and strengthen psychotherapy. There is evidence that each of these treatments, on its own, can help people with PTSD. The study will also measure personality and how each member of a pair thinks about and behaves in relationships and expresses emotions before and after having MDMA+CBCT. Pairs will have two day-long sessions scheduled two weeks apart. During the first MDMA+CBCT session, both members of the pair will receive 75 mg MDMA with the option of receiving a second dose of 37.5 approximately an hour and a half later. During the second session of MDMA+CBCT, subjects may receive either 100 or 75 mg, with the decision concerning dose made by the researchers after discussion with the subjects. An optional dose half the size of the initial dose will be offered approximately an hour and a half later. Following informed consent and screening there will be one enrollment visit over videoconference. Before the first MDMA+CBCT session, there will be an introductory session including 3 segments of CBCT psychotherapy on the day before the first MDMA session. The introductory session and the CBCT sessions will be done in person at the study site. During each MDMA+CBCT sessions, two therapists will work with with the pair. Blood pressure, heart rate and body temperature will be measured periodically during each MDMA+CBCT session. The pair will stay at the study site overnight with a night attendant on duty, and they will have an integrative psychotherapy session on the morning after the MDMA+CBCT session. Each member of the pair will be contacted by the researchers for a week after each MDMA+CBCT session. The pair will have CBCT and integrative sessions over videoconferencing twice a week for two weeks following the on-site integrative session. One month after the second MDMA+CBCT session, both participants will have an evaluation and testing visit over videoconference and will complete measures of PTSD symptoms, sleep quality, perceived growth related to experiencing a trauma, symptoms of depression, and how people think and feel about emotions and their relationships. The member of the pair with PTSD will also undergo an interview measure of PTSD symptoms. The pair will complete measures and questionnaires three and six months after the second MDMA+CBCT session. The study is open label, meaning the researchers and subjects will be aware of the doses of MDMA used in the study. The study will test and compare changes in symptoms and relationship issues before and after the course of psychotherapy.

• Posttraumatic Stress Disorder