Varenicline for Smoking Cessation in Heavy Drinking Smokers
The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Varenicline for Smoking Cessation in Heavy Drinking Smokers|
- Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. [ Time Frame: Last 4 weeks of treatment ] [ Designated as safety issue: No ]Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions.
- Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions [ Time Frame: First 3 weeks (pretreatment) ] [ Designated as safety issue: No ]Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period.
- Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions [ Time Frame: First 3 weeks (pretreatment) ] [ Designated as safety issue: Yes ]Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase
|Study Start Date:||October 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Extended Varenicline Pretreatment
Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
Other Name: chantix
Experimental: Short-term Varenicline Pretreatment
Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
Other Name: chantix
Smoking rates are elevated among drinkers compared to non-drinkers (Marks et al., 1997). Moreover, there is some evidence that both smokers who drink alcohol are less successful quitting smoking (Leeman, Huffman, & O'Malley, 2007). Thus, identifying interventions that are effective in reducing both smoking and heavy drinking in this population is warranted. Varenicline, a medication recently approved by the FDA, results in smoking cessation rates as high as 50%, significantly better than bupropion or placebo. There is preliminary experimental evidence from both animal and human laboratory research that varenicline reduces alcohol seeking and consumption (McKee, 2008; Steensland et al., 2007).
The typical dose schedule for varenicline involves a 1 week pretreatment phase prior to quitting smoking (Gonzales et al., 2006; Jorenby et al., 2006; Nides et al., 2006). However, greater quit rates have been observed 1 month after using varenicline compared to 1 week. Therefore, it is possible that extended pretreatment with varenicline may also yield better cessation outcomes than the standard 1 week lead in period. This may be particularly true if pretreatment also reduces alcohol consumption prior to the quit attempt.
Thirty regular smokers who drink alcohol heavily will receive open-label varenicline for 5 weeks according to the recommended titration schedule up to 1mg varenicline twice daily. Prior to the smoking quit date, subjects will be randomized to receive either extended pretreatment with varenicline (titration up to 1mg) for 4 weeks or short-term varenicline pretreatment (3 weeks placebo followed by 1 week of varenicline).
The primary aims of the study are to examine: (a) the efficacy of extended varenicline pretreatment for smoking cessation, (b) the safety and tolerability of varenicline in heavy drinking smokers, and (c) the efficacy of varenicline for reducing alcohol consumption in human participants. Effect size estimates for prolonged smoking abstinence and heavy drinking will be generated for a NIH grant application.
|Principal Investigator:||Stephanie S O'Malley, PhD||Yale School of Medicine|