Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2023-03-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Binge-Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NB Medication

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Group Type EXPERIMENTAL

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Intervention Type DRUG

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

Placebo

Placebo will be inactive and taken daily in pill form.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be inactive and taken daily in pill form.

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo will be inactive and taken daily in pill form.

Intervention Type OTHER

Other Intervention Names

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Contrave

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No