Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Sponsor
Yale University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03539900
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
200
1
2
85.5
2.3

Study Details

Study Description

Brief Summary

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
  • Other: Placebo
Phase 2/Phase 3

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 BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Actual Study Start Date :
Apr 17, 2018
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: NB Medication

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
Other Names:
  • Contrave
  • Placebo Comparator: Placebo

    Placebo will be inactive and taken daily in pill form.

    Other: Placebo
    Placebo will be inactive and taken daily in pill form.

    Outcome Measures

    Primary Outcome Measures

    1. Binge Eating Frequency [Post-treatment (3 months)]

      Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

    2. Binge Eating Frequency [6 months post-treatment]

      Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

    3. Binge Eating Frequency [12 months post-treatment]

      Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

    Secondary Outcome Measures

    1. Body Mass Index [Post-treatment (3 months)]

      BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.

    2. Body Mass Index [6 months post-treatment]

      BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.

    3. Body Mass Index [12 months post-treatment]

      BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);

    • BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;

    • Available for the duration of the treatment and follow-up (15 months);

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

    Exclusion Criteria:
    • Currently taking opioid pain medications or drugs; or positive drug screen for opiates

    • 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 or bulimia nervosa;

    • Pregnant or breastfeeding;

    • Medical status judged by study physician as contraindication.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale School of Medicine New Haven Connecticut United States 06520

    Sponsors and Collaborators

    • Yale University
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Carlos M Grilo, PhD, Yale School of Medicine
    • Principal Investigator: Sherry McKee, PhD, Yale School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03539900
    Other Study ID Numbers:
    • 2000021769
    • R01DK112771
    First Posted:
    May 29, 2018
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2022