A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence
This study is currently recruiting participants.
Verified July 2013 by University of Pennsylvania
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania
First received: August 28, 2012
Last updated: July 17, 2013
Last verified: July 2013
This is a double-blind placebo-controlled clinical trial (n = 200) of varenicline for the treatment of cocaine dependence that utilizes contingency management to promote treatment attendance.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase II, Randomized, Double-Blind Trial of Varenicline for the Treatment of Cocaine Dependence|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- Number of participants who report cocaine use and have positive urine drug screens in the Chantix group versus the placebo group comparator [ Time Frame: Three times per week in weeks 2 through 13 ] [ Designated as safety issue: Yes ]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 daily use/no-use indicators for each study day of treatment.
Secondary Outcome Measures:
- Number of participants who are compliant with taking medications in the Chantix group versus the placebo group comparator [ Time Frame: Three times per week during weeks 2 through 13 ] [ Designated as safety issue: No ]Measured through observed dosing at three-times-weekly clinic visits and weekly pill counts on the basis of self-reports and examination of blister packs.
- Number of participants who report cocaine craving in the Chantix group versus the placebo group comparator [ Time Frame: Once per week in weeks 2 through 13 ] [ Designated as safety issue: No ]As measured by weekly scores on the Cocaine Craving Questionnaire (CCQ) and the Minnesota Cocaine Craving Scale (MCC) during the medication treatment phase.
- Number of participants who have smoked cigarettes, both in isolation and in relation to cocaine use in the Chantix group versus the placebo group comparator. [ Time Frame: Once per week in weeks 2 through 13 ] [ Designated as safety issue: No ]Measured by carbon monoxide (CO) by CO monitor and cotinine levels using urinary cotinine dipstick testing at each clinic visit.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Oral 1.0 mg BID.
Other Name: Chantix
Placebo Comparator: Placebo
0 mg daily for 12 weeks.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680887
|Contact: Donna Simpsonfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania Treatment Research Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator: Jennifer G Plebani, PhD|
Sponsors and Collaborators
|Principal Investigator:||Jennifer G Plebani, PhD||University of Pennsylvania|