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

• Status: Enrolling by invitation
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .

• 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; Bupropion hydrochloride, naltrexone hydrochoride drug combination; Naltrexone

Criteria

Inclusion Criteria:

• Participated in acute treatment for binge-eating disorder and obesity;

• Did not have a positive response to acute treatment;

• 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; and

• 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.