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NCT Number: NCT03539900

Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

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.

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Key information

Conditions

Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Drug

NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.

Other names: Contrave

Placebo

Other

Placebo will be inactive and taken daily in pill form.

Primary outcomes

  1. Change in Binge Eating Frequency

    Time frame: Post-treatment (3 months)

    Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."

  2. Percent BMI Change

    Time frame: Post-treatment (3 months)

    BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at posttreatment] - [BMI at baseline])/[BMI at baseline]. Negative values indicate loss.

Secondary outcomes

  1. Change in Binge Eating Frequency

    Time frame: 6 months post-treatment

    Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.

  2. Change in Binge Eating Frequency

    Time frame: 12 months post-treatment

    Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.

  3. Body Mass Index

    Time frame: 6 months post-treatment

    BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 6 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.

  4. Body Mass Index

    Time frame: 12 months post-treatment

    BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 12 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
May 29, 2018
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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