Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Varenicline Treatment for Active Alcoholic Smokers
Brief Summary: Alcohol dependence is a significant and prevalent public health problem affecting approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk for both morbidity and mortality related to alcohol consumption and tobacco dependence. Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently drinking alcoholic smokers.

Varenicline is the most effective medication currently available for treating tobacco dependence. While some randomized trials have included recovering alcoholics, active alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the first such clinical trial in currently drinking alcoholic smokers. In addition to helping smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in rats. The goal of this proposal is to explore the potential efficacy of varenicline for treating tobacco dependence and reducing drinking among alcohol dependent smokers.

The investigators hypothesize that 12 weeks of treatment with varenicline, a partial nicotinic acetylcholine receptor agonist will be more effective than placebo in treating tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic smokers. The investigators will also explore whether varenicline has an effect on drinking behavior among currently drinking alcoholics. The investigators propose the following specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited at the Mayo Clinic in Rochester, Minnesota.


Options:
A: Arm Label: Varenicline + Placebo Patch; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Drug: Placebo Patch, Behavioral: Questionnaires, Behavioral: Counseling Sessions, Other: Lab Session, Other: Saliva Test | Arm Label: Nicotine Patch + Placebo Tablet; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Patch, Drug: Placebo Tablet, Behavioral: Questionnaires, Behavioral: Counseling Sessions, Other: Lab Session, Other: Saliva Test | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline + Placebo Patch | Intervention Type: DRUG; Name: Nicotine Patch; Assigned to Arm(s): Nicotine Patch + Placebo Tablet | Intervention Type: DRUG; Name: Placebo Patch; Assigned to Arm(s): Varenicline + Placebo Patch | Intervention Type: DRUG; Name: Placebo Tablet; Assigned to Arm(s): Nicotine Patch + Placebo Tablet | Intervention Type: BEHAVIORAL; Name: Questionnaires; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch | Intervention Type: BEHAVIORAL; Name: Counseling Sessions; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch | Intervention Type: OTHER; Name: Lab Session; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch | Intervention Type: OTHER; Name: Saliva Test; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch
B: Arm Label: Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Sugar Pil; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Sugar Pil
C: Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline | Arm Label: placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
D: Arm Label: Active bupropion-Active gum; Type: ACTIVE_COMPARATOR; Interventions: Drug: bupropion + nicotine gum | Arm Label: Active bupropion-Placebo gum; Type: ACTIVE_COMPARATOR; Interventions: Drug: Active bupropion-Placebo gum | Arm Label: Placebo medication-Placebo gum; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo bupropion-Placebo gum | Intervention Type: DRUG; Name: bupropion + nicotine gum; Assigned to Arm(s): Active bupropion-Active gum | Intervention Type: DRUG; Name: Active bupropion-Placebo gum; Assigned to Arm(s): Active bupropion-Placebo gum | Intervention Type: DRUG; Name: Placebo bupropion-Placebo gum; Assigned to Arm(s): Placebo medication-Placebo gum

Answer: B