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Completed

NCT Number: NCT03063606

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment

This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .

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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 (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).

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;
  • Did not have 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 weekly 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

Cognitive-Behavioral Therapy (CBT)

Behavioral

CBT specialist treatment

NB Medication (on-going from acute treatment)

Drug

Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)

Other names: Contrave

Primary outcomes

  1. Binge Eating Frequency (Continuous)

    Time frame: Post-treatment (4 months)

    Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.

  2. Change in Body Mass Index at 4 Months Post-Treatment From Baseline

    Time frame: Baseline and Post-treatment (4 months)

    BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline

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).

Other outcomes

  1. Body Mass Index

    Time frame: 12-Month Follow-up

    BMI is calculated using measured height and weight (e.g., percent loss).

  2. Body Mass Index

    Time frame: 6-Month Follow-up

    BMI is calculated using measured height and weight (e.g., percent 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 24, 2017
Registry last updated
Feb 1, 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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