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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
MDMA-AT
DrugMDMA-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
DrugMDMA-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)
BehavioralStandard Treatment (ST) for BN assignment includes weekly therapy sessions for 22 weeks.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: MDMA-ATExperimental treatment 1 intervention
Group B: MDMA-AT-BNExperimental treatment 1 intervention
Group C: Standard Treatment (ST)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Binge Eating Episode Frequency
Eating Disorder Examination Questionnaire (EDEQ) is administered to assess psychopathology of eating disorders using 28 items. Binge eating frequency (count of binge eating episodes) is a question measured in this assessment. Higher frequency indicates higher severity.
Time frame
Up to 6 monthsSecondary outcomes
1
Binge Eating Severity
Eating Disorder Examination Questionnaire (EDEQ) is a self-report measure assessing psychopathology of eating disorders using 28 items. Global score ranges from 0 to 6 with higher scores indicating symptoms of higher severity. Scores will be calculated between baseline and 6-months.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov