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N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

NCT01214083 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2020-04-08

Study results available
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Summary

The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.

Conditions

  • Alcoholism

Interventions

DRUG

N-acetylcysteine + high-dose naltrexone (150 mg)

All subjects will be evaluated weekly for 12 weeks.

DRUG

High-dose naltrexone (150 mg) alone

All subjects will be evaluated weekly for 12 weeks.

DRUG

Low-dose naltrexone (50 mg) alone

All subjects will be evaluated weekly for 12 weeks.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Gihyun Yoon, MD · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-15
Primary Completion
2015-09-30
Completion
2016-10-30
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 NCT01214083 on ClinicalTrials.gov