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

Last updated: February 1, 2024
Sponsor: Yale University
Overall Status: Completed

Phase

2/3

Condition

Obesity

Bulimia

Binge Eating Disorder

Treatment

NB medication (Naltrexone Bupropion combination)

Placebo

Clinical Study ID

NCT03047005
1506016065-M
R01DK049587
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-relatedmaterials; and
  • Able to travel to study location (New Haven, CT) for monthly visits.

Exclusion

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.

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: NB medication (Naltrexone Bupropion combination)
Phase: 2/3
Study Start date:
August 28, 2017
Estimated Completion Date:
December 16, 2022

Study 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.

Connect with a study center

  • Yale School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

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