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

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Binge-Eating Disorder; Obesity

Treatments: Drug: NB medication (Naltrexone Bupropion combination); Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03047005

R01DK049587 (U.S. NIH Grant/Contract)

1506016065-M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

NB medication

Experimental group

Description:

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.

Treatment:

Drug: NB medication (Naltrexone Bupropion combination)

Placebo

Placebo Comparator group

Description:

Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Treatment:

Other: Placebo