CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 111 enrolled
Drug / intervention
N-acetylcysteine + high-dose naltrexone (150 mg) +2 moredrug
Likely dose
N-acetylcysteine + high-dose naltrexone (150 mg)from 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/NCT01214083
NCT01214083Phase 2Completed
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N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

VA Office of Research and Development·interventional·Posted Oct 4, 2010·Updated Apr 8, 2020

In Brief

A Phase 2 clinical trial evaluating N-acetylcysteine + high-dose naltrexone (150 mg), High-dose naltrexone (150 mg) alone, and 1 other intervention for Alcoholism. Completed, enrolled 111 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 4, 2010
Enrollment StartOct 15, 2010
Primary CompletionSep 30, 2015
Study CompletionOct 30, 2016
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 15.7 years ago

Interventions

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

All subjects will be evaluated weekly for 12 weeks.

High-dose naltrexone (150 mg) alonedrug

All subjects will be evaluated weekly for 12 weeks.

Low-dose naltrexone (50 mg) alonedrug

All subjects will be evaluated weekly for 12 weeks.