Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

Phase 2

Completed

• Conditions: Binge-Eating Disorder; Obesity
• Interventions: Drug: NB medication (Naltrexone Bupropion combination); Other: Placebo

• Registration Number: NCT03047005
• Lead Sponsor: Yale University

Brief Summary

This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Detailed Description

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

Study Timeline

• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-08
• Study Start: 2017-08-28
• Primary Completion: 2021-12-16
• Results First Submitted: 2022-11-30
• Study Completion: 2022-12-16
• Results First Submitted QC: 2023-04-14
• Results First Posted: 2023-05-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Participated in acute treatment for binge-eating disorder and obesity;
• Had 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 monthly visits.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NB medication	NB medication (Naltrexone Bupropion combination)	Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
Placebo	Placebo	Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Primary Outcome Measures

Name	Time	Method
Binge Eating Frequency (Continuous)	Post-treatment (4 months)	Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Change in Body Mass Index	baseline and Post-treatment (4 months)	BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.

Secondary Outcome Measures

Name	Time	Method
Binge Eating Frequency (Continuous)	12-Month Follow-up	Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Change in Body Mass Index (BMI)	Baseline to 6-Month Follow-up	BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
Change in Body Mass Index	Baseline to 12-Month Follow-up	BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States