Varenicline (Chantix™) for the Treatment of Alcohol Dependence (ChA)
The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence.
|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 Pilot Trial of Varenicline (Chantix™) for the Treatment of Alcohol Dependence|
- Rate of Heavy Drinking Days Per Week. [ Time Frame: 12 weeks of treatment and one month follow-up ] [ Designated as safety issue: No ]Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).
- Addiction Severity Index (ASI) Alcohol Composite Score at End of Study. [ Time Frame: 12 weeks of treatment, with a follow-up one month after treatment ] [ Designated as safety issue: No ]The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.
|Study Start Date:||June 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
1.0 mg BID for 12 weeks
Other Name: Chantix
|Placebo Comparator: 2||
BID 12 weeks
By both providing a low level of reinforcement and down-grading any "high" associated with concurrent administration of the abused drug, combined agonist/antagonist therapies promote both initial and sustained abstinence. Based on varenicline's specific affinity for the nicotinic acetylcholine receptors that are implicated in alcohol reward circuitry, it appears to be a good candidate for treatment of alcohol dependence. Alcohol can exert its reinforcing and dopamine-enhancing effects through activation of nicotinic receptors. In addition to its partial agonist activity at heteromeric α4β2 nicotinic acetylcholine receptors, varenicline has also been shown to be a full agonist at homomeric α7 nicotinic acetylcholine receptors. That full agonism at α7 may be key in reducing alcohol withdrawal and craving during early alcohol abstinence, and thus reducing relapse, as α7 receptors are implicated in the neural reward circuitry activated by alcohol use.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705523
|United States, Pennsylvania|
|University of Pennsylvania Treatment Research Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jennifer G Plebani, PhD||University of Pennsylvania, Treatment Research Center|