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NCT00585780 · ClinicalTrials.gov registry record · Phase 1
Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT00585780: Completed Phase 1 study, sponsored by Yale University.
NCT00585780 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585780, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of Prazosin on brief exposure to stress, drug cues and neutral situations on alcohol and drug craving, mood and neurobiological reactivity in a sample of cocaine and/or alcohol dependent individuals. Prazosin will be beneficial for reduction in stress and alcohol cue induced craving and related arousal. In a sample of treatment-seeking alcohol dependent men and women, we propose to examine (a) differences in measures of alcohol craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to alcohol cue imagery as compared to neutral imagery; (b) reduction in alcohol abstinence symptoms; and (c) improvement in alcohol treatment outcomes as measured by reductions in heavy drinking days, any drinking days, secondarily on drinks/day, anxiety, mood and sleep.
Primary Outcome
Percentage of heavy drinking days (HDD%) during the full dose period from weeks 3-12 where heavy drinking day (HDD) is defined as 5 or more for men and 4 or more for women in one sitting, measured as yes (1) or no(0), assessed via self reports by daily surveys and time-line follow back assessments
Interventions
- DRUG Placebo Tablet
- DRUG Prazosin Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-09 |
| Est. Completion | 2019-05-13 |
| Phase | Phase 1 |
What the finished NCT00585780 record still lists
NCT00585780 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Tablet is the first listed.
NCT00585780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585780 about?
NCT00585780 is a clinical study titled "Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse". To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of Prazosin on brief exposure to stress, drug cues and neutral situations on alcohol and d...
What is the current status of trial NCT00585780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2009-09. Estimated completion is 2019-05-13.
What interventions are being tested in trial NCT00585780?
The interventions under investigation include: Placebo Tablet (DRUG), Prazosin Tablet (DRUG).
Who is sponsoring clinical trial NCT00585780?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00585780's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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