MDMA Assisted Therapy for BN

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07542145
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Bulimia Nervosa

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MDMA-AT — DRUG
    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.
  • MDMA-AT-BN — DRUG
    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.
  • Standard Treatment (ST) — BEHAVIORAL
    Standard Treatment (ST) for BN assignment includes weekly therapy sessions for 22 weeks.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MDMA-AT
    This 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.
  • Experimental: MDMA-AT-BN
    This 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.
  • Active Comparator: Standard Treatment (ST)
    This assignment includes weekly therapy sessions for 22 weeks.

Primary Outcome Measure

Binge Eating Episode Frequency [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Psychiatry, Eating and Weight Disorders ProgramNew YorkNew York10028
Carson Harran
[email protected]
212-659-8724
Tom Hildebrandt (PRINCIPAL_INVESTIGATOR)

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By research site
Department of Psychiatry, Eating and Weight Disorders Program· New York, NY

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