Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

• Status: Active, not recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Bupropion; Naltrexone

Criteria

Inclusion Criteria:

• Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)

• BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;

• Available for the duration of the treatment and follow-up (20 months);

• Read, comprehend, and write English at a sufficient level to complete study-related materials;

• Able to travel to study location (New Haven, CT) for weekly visits.

Exclusion Criteria:

• Currently taking anti-depressant medications;

• Currently taking opioid pain medications or drugs;

• Currently taking medications that influence eating/weight;

• History of seizures;

• Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);

• Past or current anorexia nervosa, bulimia nervosa;

• Pregnant or breastfeeding;

• Medical status judged by study physician as contraindication.