CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Bupropion +1 moredrug
Likely dose
Bupropion 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03169244
NCT03169244Phase 2Completed
CompareCT.gov

Efficacy and Safety of the Melanocortin Activator Bupropion in Treating Binge Drinking

University of North Carolina, Chapel Hill·interventional·Posted May 30, 2017·Updated Aug 26, 2020

In Brief

A Phase 2 clinical trial evaluating Bupropion and Placebo Oral Tablet for Alcohol Abuse. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The present proposal is an innovative and translational clinical trial derived from exciting preclinical findings to test the hypothesis that treatment with the melanocortin activator bupropion can reduce binge drinking in humans. Furthermore, pilot data on moderating effects of coexisting nicotine use on the efficacy of bupropion for binge drinking population will be obtained. Evidence for an efficacy signal with good tolerability with this FDA approved medication would form the foundation to conduct a well-powered Phase II b trial. The development of an effective pharmacotherapy for binge drinking would be a significant clinical advance. .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Abuse
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartSep 4, 2017
Primary CompletionAug 19, 2019
Study CompletionSep 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.1 years ago

Interventions

Bupropiondrug

Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.

Placebo Oral Tabletdrug

Placebo will be initiated on Day 1 and continue throughout the course of the study.