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Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

NCT03539900 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2024-04-03

Study results available
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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.

Conditions

  • Binge-Eating Disorder

Interventions

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

Placebo

Placebo will be inactive and taken daily in pill form.

Sponsors & Collaborators

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

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Carlos M Grilo, PhD · Yale University

  • Sherry McKee, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2022-04-19
Completion
2023-03-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03539900 on ClinicalTrials.gov