Trial · NCT00567320
Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
NCT00567320, Not applicable, Completed, Yale University; results first posted 2012-04-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Varenicline in Methadone-Stabilized Cocaine Users. Trials, record NCT00567320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00567320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
- NCT number
- NCT00567320
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 31 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Cocaine Dependence, Nicotine Dependence
- Interventions
- Varenicline, Sugar pill or Placebo
- First posted
- 2007-12-04
- Last updated
- 2020-04-02
- Results first posted
- 2012-04-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Cocaine Positive Urine Tests Per Week | Weekly Measures over 12 weeks | 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) analysis using a total of 13 longitudinal results that included a baseline result (Week 0). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Cocaine Positive Urine Tests Per Week | Weekly Measures over 12 weeks | Intention to treat analysis of all subjects receiving medication | Proportion of cocaine positive | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Cocaine Positive Urine Tests Per Week | Varenicline | .57 | Standard Deviation .05 | Proportion of cocaine positive | |
| Proportion of Cocaine Positive Urine Tests Per Week | Placebo | .58 | Standard Deviation .05 | Proportion of cocaine positive |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 13 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Varenicline | 13 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Varenicline | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Varenicline | 0 | 13 |
| Total, other adverse events | Placebo | 0 | 16 |
| Total, serious adverse events | Varenicline | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA021264 | Pharmacotherapy & CM for Opioid and Cocaine Dependence | SOFUOGLU, MEHMET | YALE UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2007 to 2012 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Varenicline vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00567320
GET https://conductscience.org/api/trials/v1/NCT00567320/registered