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An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

NCT02842073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-12-26

Study results available
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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.

Conditions

  • Binge Drinking

Interventions

DRUG

Naltrexone

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.

DRUG

Bupropion

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.

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • James Garbutt · UNC Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
34 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2017-12-13
Completion
2017-12-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02842073 on ClinicalTrials.gov