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NCT00567320 · ClinicalTrials.gov registry record · NA
Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT00567320: Completed NA study, sponsored by Yale University.
NCT00567320 is a NA study that has completed, run by Yale University. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00567320, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist. 1. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects. 2. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.
Primary Outcome
Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysi
Interventions
- DRUG Varenicline
- DRUG Sugar pill or Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-08 |
| Phase | NA |
What the finished NCT00567320 record still lists
NCT00567320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Varenicline is the first listed.
NCT00567320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00567320 about?
NCT00567320 is a clinical study titled "Efficacy of Varenicline in Methadone-Stabilized Cocaine Users". Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine u...
What is the current status of trial NCT00567320?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2007-03. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00567320?
The interventions under investigation include: Varenicline (DRUG), Sugar pill or Placebo (DRUG).
Who is sponsoring clinical trial NCT00567320?
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 NCT00567320's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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