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: Nicotine E-Cigarette and Counseling; Type: EXPERIMENTAL; Interventions: Other: Nicotine E-Cigarette, Behavioral: Counseling | Arm Label: Non-Nicotine E-Cigarette and Counseling; Type: OTHER; Interventions: Other: Non-Nicotine E-Cigarette, Behavioral: Counseling | Arm Label: Counseling; Type: OTHER; Interventions: Behavioral: Counseling | Intervention Type: OTHER; Name: Nicotine E-Cigarette; Assigned to Arm(s): Nicotine E-Cigarette and Counseling | Intervention Type: OTHER; Name: Non-Nicotine E-Cigarette; Assigned to Arm(s): Non-Nicotine E-Cigarette and Counseling | Intervention Type: BEHAVIORAL; Name: Counseling; Assigned to Arm(s): Counseling, Nicotine E-Cigarette and Counseling, Non-Nicotine E-Cigarette and Counseling
B: Arm Label: E-cigarettes device plus liquid; Type: EXPERIMENTAL; Interventions: Device: E-cigarettes device plus liquid | Arm Label: Nicotine Pouches; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Pouches | Arm Label: Basic care counseling about smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Other: Basic care counseling about smoking cessation | Intervention Type: DEVICE; Name: E-cigarettes device plus liquid; Assigned to Arm(s): E-cigarettes device plus liquid | Intervention Type: DRUG; Name: Nicotine Pouches; Assigned to Arm(s): Nicotine Pouches | Intervention Type: OTHER; Name: Basic care counseling about smoking cessation; Assigned to Arm(s): Basic care counseling about smoking cessation
C: Arm Label: Varenicline treatment as usual (TAU); Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: Varenicline directly observed therapy; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline directly observed therapy, Varenicline treatment as usual (TAU)
D: 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

Answer: D