MDMA Assisted Therapy for BN
ConditionBulimia Nervosa
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Alanine transaminase (ALT) [or aspartate transaminase (AST)] > 2 x upper limit of normal (ULN). Total bilirubin > 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin < 35%).
Estimated glomerular filtration rate (eGFR) less than 60.
Current unstable liver or biliary disease per investigator assessment defined by presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of hepatitis B surface antigen or positive hepatitis C antibody test result without evidence of active infection at screening or within 3 months prior to starting study intervention) is acceptable if the participant otherwise meets entry criteria.
Self-induced vomiting of over 14 times per week
Trial design
Treatments tested in this trial
- MDMA-AT
- MDMA-AT-BN
- Standard Treatment (ST)
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov