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NCT00585754 · ClinicalTrials.gov registry record · Phase 1
Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00585754: Completed Phase 1 study, sponsored by Yale University.
NCT00585754 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585754, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of guanfacine on brief exposure to stress, drug cues and neutral situations on cocaine/alcohol craving, mood and neurobiological reactivity in a sample of cocaine and/or alcohol dependent individuals. Guanfacine will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 60 cocaine and/or alcohol dependent men and women, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine/alcohol abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment attendance. Hypothesis 1: Guanfacine will decrease stress-induced cocaine craving, negative emotions and related arousal in the laboratory as compared to placebo. Hypothesis 2a: As compared to the PLA group, the GFC group will show significant reductions in protracted withdrawal symptoms as measured by the CSSA/CIWA during the 9-week treatment period. Hypothesis 2b: As compared to the PLA group, a higher percentage of the GFC patients will remain abstinent during the 9-week treatment period with a higher percent of negative cocaine urines and alcohol-free days. Hypothesis 2c: The GFC group will show greater adherence to treatment as measured by the days in treatment as compared to the Pla group.
Interventions
- DRUG Placebo
- DRUG Guanfacine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2006-04 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT00585754 record still lists
NCT00585754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00585754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585754 about?
NCT00585754 is a clinical study titled "Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse". This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of guanfacine on brief exposure to stress, drug cues and neutral situa...
What is the current status of trial NCT00585754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2006-04. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00585754?
The interventions under investigation include: Placebo (DRUG), Guanfacine (DRUG).
Who is sponsoring clinical trial NCT00585754?
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 NCT00585754's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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