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

NCT03047005 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 1506016065-MR01DK049587
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Binge-Eating Disorder; Obesity

Outcome Measures

Primary Outcomes (2)

• Binge Eating Frequency (Continuous)

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

  Post-treatment (4 months)

• Change in Body Mass Index

  BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.

  baseline and Post-treatment (4 months)

Secondary Outcomes (4)

• Binge Eating Frequency (Continuous)

  6-Month Follow-up

• Binge Eating Frequency (Continuous)

  12-Month Follow-up

• Change in Body Mass Index (BMI)

  Baseline to 6-Month Follow-up

• Change in Body Mass Index

  Baseline to 12-Month Follow-up

Study Arms (2)

NB medication

EXPERIMENTAL

Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.

Drug: NB medication (Naltrexone Bupropion combination)

Placebo

PLACEBO COMPARATOR

Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Other: Placebo

Interventions

NB medication (Naltrexone Bupropion combination) DRUG

NB medication

Also known as: Contrave

NB medication

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity

Interventions

Naltrexone-Bupropion combination; bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Carlos Grilo
• Organization: Yale University

carlos.grilo@yale.edu

203 785 7210

Study Officials

• Carlos M Grilo, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 8, 2017
• Study Start: August 28, 2017
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2022
• Last Updated: February 2, 2024
• Results First Posted: May 6, 2023

Record last verified: 2024-02

Locations

US (1)