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Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

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ClinicalTrials.gov Identifier: NCT00567320
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : April 9, 2012
Last Update Posted : February 6, 2013
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs
Information provided by (Responsible Party):
James Poling, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Conditions Cocaine Dependence
Nicotine Dependence
Interventions Drug: Varenicline
Drug: Sugar pill or Placebo
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline 2 mg per day. This is the Placebo condition
Period Title: Overall Study
Started 13 18
Completed 13 18
Not Completed 0 0
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description Varenicline 2 mg per day. This is the Placebo condition Total of all reporting groups
Overall Number of Baseline Participants 13 18 31
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 18 participants 31 participants
36.5  (12) 34.4  (12) 35.45  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 18 participants 31 participants
Female
2
  15.4%
4
  22.2%
6
  19.4%
Male
11
  84.6%
14
  77.8%
25
  80.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 18 participants 31 participants
13 18 31
1.Primary Outcome
Title Proportion of Cocaine Positive Urine Tests Per Week
Hide Description 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).
Time Frame Weekly Measures over 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis of all subjects receiving medication
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 2 mg per day.
This is the Placebo condition
Overall Number of Participants Analyzed 13 16
Mean (Standard Deviation)
Unit of Measure: Proportion of cocaine positive
.57  (.05) .58  (.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments HLM analysis of % of Cocaine Positive Urines per week over 12 weeks. Subjects were used as a Random variable, with medication dosing set to 'Fixed'.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline 2 mg per day. This is the Placebo condition
All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mehmet Sofuoglu, M.D., Ph.D.
Organization: Yale University
Phone: 203-937-4809
Responsible Party: James Poling, Yale University
ClinicalTrials.gov Identifier: NCT00567320     History of Changes
Other Study ID Numbers: MIRECC 000000000
R01DA021264 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
MIRECC 000000000 ( Registry Identifier: Department of Veterans Affairs )
First Submitted: December 3, 2007
First Posted: December 4, 2007
Results First Submitted: February 8, 2012
Results First Posted: April 9, 2012
Last Update Posted: February 6, 2013