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NCT01980706 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of High Dose Baclofen for Alcohol Dependence
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT01980706: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT01980706 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980706, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.
Primary Outcome
The frequency of heavy drinking days (5 or more drinks for a man and 4 or more drinks for a woman) as percentage during the treatment phase.
Interventions
- DRUG Placebo
- DRUG Baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2013-12-12 |
| Est. Completion | 2017-10-26 |
| Phase | Phase 2 |
What the finished NCT01980706 record still lists
NCT01980706 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01980706 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01980706 about?
NCT01980706 is a clinical study titled "Efficacy and Safety of High Dose Baclofen for Alcohol Dependence". The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. ...
What is the current status of trial NCT01980706?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2013-12-12. Estimated completion is 2017-10-26.
What interventions are being tested in trial NCT01980706?
The interventions under investigation include: Placebo (DRUG), Baclofen (DRUG).
Who is sponsoring clinical trial NCT01980706?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01980706's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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