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Completed

NCT Number: NCT03047005

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

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.

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Key information

Conditions

Binge-Eating Disorder Body Weight Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

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 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

NB medication (Naltrexone Bupropion combination)

Drug

NB medication

Other names: Contrave

Placebo

Other

Placebo

Primary outcomes

  1. Binge Eating Frequency (Continuous)

    Time frame: 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).

  2. Change in Body Mass Index

    Time frame: 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 outcomes

  1. Binge Eating Frequency (Continuous)

    Time frame: 6-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).

  2. Binge Eating Frequency (Continuous)

    Time frame: 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).

  3. Change in Body Mass Index (BMI)

    Time frame: 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.

  4. Change in Body Mass Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Feb 8, 2017
Registry last updated
Feb 2, 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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