NCT01214083

N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50 mg) will be compared in a 12-week randomized, double-blind clinical trial.

Conditions

• Alcoholism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-15
• Primary completion: 2015-09-30
• Completion: 2016-10-30
• First posted: 2010-10-04
• Last updated: 2020-04-08
• Results posted: 2017-03-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study