A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence
|ClinicalTrials.gov Identifier: NCT01680887|
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: Varenicline Drug: Placebo||Phase 2|
Background: Varenicline is a medication approved for the treatment of Tobacco Use Disorder. It is a partial agonist at α2β4 nicotinic acetyl choline receptors and a full agonist at α7 nicotinic acetyl choline receptors. By its effects on cholinergic activity at α7 and α2β4 receptors, varenicline may reduce dopaminergic and glutamatergic activity in the midbrain, and reduce symptoms of Cocaine Use Disorder. A preliminary trial of varenicline in human cocaine users suggested that varenicline treatment was associated with reductions in cocaine use. The current trial was intended to confirm these promising preliminary results.
Methods: This was a 12-week, double blind, placebo controlled parallel group clinical trial involving 156 DSM IV cocaine dependent subjects. Subjects received 2 mg of varenicline or identical placebo each day along with weekly individual cognitive behavioral relapse prevention psychotherapy. The primary outcome measure was cocaine use measured by by thrice weekly urine drug screens. Additional outcome measures included cocaine withdrawal symptoms measured by the Cocaine Selective Severity Assessment (CSSA) End of study cocaine abstinence was analyzed using a Chi-square test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Randomized, Double-Blind Trial of Varenicline for the Treatment of Cocaine Dependence|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||June 2019|
Oral 1.0 mg BID.
Other Name: Chantix
Placebo Comparator: Placebo
Oral 1.0 mg BID.
- Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial [ Time Frame: weeks 11,12,13 of the trial ]Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment.
- Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator [ Time Frame: Once per week in weeks 2 through 13 ]As measured by average weekly scores for cocaine craving on the brief substance craving scale combining cocaine craving frequency, intensity and duration. Minimum value 0 maximum value 12 higher scores indicate worse craving.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680887
|United States, Pennsylvania|
|University of Pennsylvania Treatment Research Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Kyle M Kampman, MD||University of Pennsylvania|