CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Naltrexone 50 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/NCT02842073
NCT02842073Phase 2Completed
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Assessing Changes in the Brain Melanocortin System and Sensory Processing in Response to Alcohol to Advance Our Understanding of the Pathophysiology and Psychopharmacology of Binge Drinking

University of North Carolina, Chapel Hill·interventional·Posted Jul 22, 2016·Updated Dec 26, 2018

In Brief

A Phase 2 clinical trial evaluating Naltrexone and Bupropion for Binge Drinking. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge Drinking
CountriesUnited States
CollaboratorsNorth Carolina Translational and Clinical Sciences Institute

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 22, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.9 years ago

Interventions

Naltrexonedrug

Standard clinical doses of naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84.

Bupropiondrug

Standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.