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NCT01214083 · ClinicalTrials.gov registry record · Phase 2
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
NCT01214083: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT01214083 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 111 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01214083, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
Study 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.
Primary Outcome
"Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking).
Interventions
- DRUG N-acetylcysteine + high-dose naltrexone (150 mg)
- DRUG High-dose naltrexone (150 mg) alone
- DRUG Low-dose naltrexone (50 mg) alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2010-10-15 |
| Est. Completion | 2016-10-30 |
| Phase | Phase 2 |
What the finished NCT01214083 record still lists
NCT01214083 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which N-acetylcysteine + high-dose naltrexone (150 mg) is the first listed.
NCT01214083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01214083 about?
NCT01214083 is a clinical study titled "N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence". 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) alo...
What is the current status of trial NCT01214083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2010-10-15. Estimated completion is 2016-10-30.
What interventions are being tested in trial NCT01214083?
The interventions under investigation include: N-acetylcysteine + high-dose naltrexone (150 mg) (DRUG), High-dose naltrexone (150 mg) alone (DRUG), Low-dose naltrexone (50 mg) alone (DRUG).
Who is sponsoring clinical trial NCT01214083?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01214083's enrollment target sits among peer trials
111 632nd of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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