MDMA Assisted Therapy for Bulimia Nervosa

Overseen By Carson Harran

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Psychiatric medications, QT prolonging drugs

Disqualifiers: Liver disease, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Tom Hildebrandt, PsyD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Inclusion Criteria

Agrees to have study visits recorded, including Experimental Sessions and non-medication therapy sessions

Live within reasonable driving distance of the study site (equal to or less than an estimated 2-hour drive from the study site)

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

Exclusion Criteria

Hypersensitivity to any ingredient of the IMP

I have had electroconvulsive therapy (ECT) in the past 12 weeks.

Current moderate or severe alcohol or cannabis use disorder within the 12 months prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MDMA-preparation

Preparation phase for MDMA-assisted therapy, including baseline assessments

1 week

Intervention

Participants undergo MDMA-assisted psychotherapy sessions and integrative sessions

10 weeks

3 experimental sessions, 9 integrative sessions, 12 weekly therapy sessions

Standard Treatment

Participants receive weekly therapy sessions focusing on BN

22 weeks

22 weekly therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• MDMA Assisted Therapy

How Is the Trial Designed?

Group I: MDMA-AT-BN Experimental Treatment 1 Intervention

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.

Group II: MDMA-AT Experimental Treatment 1 Intervention

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.

Group III: Standard Treatment (ST) Active Control 1 Intervention

This assignment includes weekly therapy sessions for 22 weeks.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+