MDMA Assisted Therapy for Bulimia Nervosa: A Treatment Development Protocol
Icahn School of Medicine at Mount Sinai
Summary
This project will evaluate MDMA Assisted Therapy (MDMA-AT) assisted psychotherapy for the treatment of Bulimia Nervosa (BN) over a 10-week period. Preliminary data suggests that MDMA can facilitate heightened openness and reduce anxiety. This study will determine whether MDMA-assisted therapy can serve as a new treatment for BN. Participants are assigned to one of three groups: MDMA-AT, MDMA-AT-BN, and Standard Treatment (ST). MDMA groups include three experimental session that include dosing, which are each followed by three integrative sessions and also include 12 psychotherapy sessions. A follow-up will take place at 6-months post baseline.
Description
Three groups (MDMA-AT, MDMA-AT-BN, and ST) will be compared on changes in Binge Eating frequency, severity of symptoms, body image, weight, retention, acceptability of treatment, motivation, and safety. Assessments include a screening phase, baseline, MDMA-preparation phase, intervention, and a follow-up. MDMA-AT includes 3 sessions of MDMA-assisted psychotherapy, 9 integrative sessions that involve discussing the experiences during MDMA sessions and processing thoughts, emotions, and distress. Additionally, 12 weekly non-specific therapy sessions take place after the dosing and integrative se…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants will be included in the protocol if they meet the following criteria: * At least 18 years of age * Meet criteria for Bulimia Nervosa as measured by the EDA-5 * Able to provide written, informed consent * Able to swallow pills * Agree to have study visits recorded, including Experimental Sessions and non-medication therapy sessions * Provides a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable * Agrees to inform the investiga…
Interventions
- DrugMDMA-AT
MDMA-AT assisted psychotherapy (MDMA-AT) assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of non-specific eating disorder psychotherapy.
- DrugMDMA-AT-BN
MDMA-AT assisted psychotherapy specific to BN (MDMA-AT-BN) assignment includes 3 experimental (medicine) sessions, occurring 3 weeks apart and 9 integrative sessions over the course of 10 weeks. These are followed by 12 sessions of BN-specific eating disorder psychotherapy.
- BehavioralStandard Treatment (ST)
Standard Treatment (ST) for BN assignment includes weekly therapy sessions for 22 weeks.
Location
- Department of Psychiatry, Eating and Weight Disorders ProgramNew York, New York