Varenicline for Smoking Cessation in Heavy Drinking Smokers
Condition: Nicotine Dependence; Smoking; Heavy Drinking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Extended Varenicline Pretreatment; Short-term Varenicline Pretreatment
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): chantix; Placebo
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Smoking cessation; Smoking; Tobacco; Varenicline; Alcohol