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Mediators and Moderators of Combined Varenicline and Naltrexone for Smoking Cessation

Institution: University of California, Los Angeles
Investigator(s): ReJoyce Green,
Award Cycle: 2019 (Cycle 30) Grant #: T30DT0950 Award: $89,671
Subject Area: Tobacco-Use Prevention and Cessation
Award Type: Dissertation Awards

Initial Award Abstract
Heavy drinking smokers constitute a sub-population of smokers with a distinct clinical profile and treatment needs. Currently, there are no available pharmacological treatments tailored to heavy drinking smokers who wish to quit smoking. One of the ways in which treatments can be optimized is through the combination of effective pharmacotherapies for smoking and drinking. Varenicline (VAR) is an FDA approved smoking cessation medication that has also been shown to reduce alcohol craving and consumption. Naltrexone (NTX) is an FDA approved medication for alcohol use disorder that has been shown to improve smoking quite rates in heavy drinking smokers. Together these medications may offer a promising pharmacotherapy option for heavy drinking smokers. Various gender differences exist in relation to cigarette use. Women have been shown to experience greater nicotine withdrawal symptoms, craving, and negative affect in comparison to men when trying to quite smoking. Women have also been shown to have less success than men when they do attempt to quit smoking. These gender differences may be due to hormone levels because of the menstrual cycle or hormonal contraceptive use. The proposed project aims to examine possible pathways through which these two medications, varenicline and naltrexone, can alter smoking quit outcomes, as well as how gender plays a role in the effects of these two medications. The proposed project will be using data that is currently being conducted as part of a clinical trial examining the effects of VAR alone versus the combination of VAR + NTX for smoking cessation in a sample of heavy-drinking daily smokers. Participants set a quit date for smoking as part of the study. All participants are instructed to continue the study medications for 12 weeks and will return to the laboratory for follow-ups 2, 8, 12, 16, and 26 weeks post quit date. The proposed project will examine how nicotine withdrawal may serve as one pathway by which these medications are having an effect. The proposed project will also examine if there are difference in men and women on these two medications, and examining within women how hormone levels, hormonal contraceptive use, and menstrual cycle phase predict smoking abstinence.