Grant Number:	1R37CA309045-01 Interpret this number
Primary Investigator:	Miguel, Andre
Organization:	Washington State University
Project Title:	App-Based Contingency Management and Varenicline Telehealth Intervention for Rural Heavy-Drinking Smokers.
Fiscal Year:	2026

PROJECT SUMMARY/ABSTRACT Alcohol use and Tobacco smoking remains the leading cause of preventable death in the United States and are key contributors to the increased morbidity and mortality burden of rural America. Roughly 60–70% of tobacco smokers binge drink or frequently consume dangerous amounts of alcohol, and over 75% of people with an Alcohol Use Disorder (AUD) are people who smoke. Telehealth interventions for substance use disorders may optimize care for rural communities by removing important barriers such as access to treatment, and costs and travel time associated with commute. Recent advances have enabled Contingency Management (CM) mobile applications (apps) to connect to low-cost breathalyzer devices enabling the provision of inexpensive and accessible app-based CM for AUD to anyone who owns a smartphone. Varenicline (VC), the frontline medical treatment for smoking cessation, has shown to be the most effective smoking cessation pharmacotherapy among smokers with an AUD. This trial will be first-in-science to implement a completely remote telehealth intervention composed of VC and app-based CM to treat smokers with an AUD living in rural communities. We will use ecological momentary assessment (EMA) embedded in our CM app to explore how within-subject fluctuations in the three Addiction Neuroclinical Assessement (ANA) domains interact with daily drinking and smoking. In order to increase our methodological rigour, we will use PILLSY to monitor and promote VC adherence, and will for the first time collect 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), to determine smoking status. A total of n=192 smokers with an AUD living in rural communities and seeking smoking cessation treatment will take part in a RCT to evaluate the ability of VC plus app-based CM to promote reductions in alcohol use and smoking. Participants will be randomized to one of two 12-week treatment conditions: 1) VC plus app-based CM (VC+CM- experimental condition), or 2) VC plus app-based non-contingent control (VC+NC- control condition). Follow-up will occur 1, 3 and 6 months after end of treatment. Our Specific Aims are to determine if those randomized to the VC+CM are more likely than controls to 1) submit daily breathalyzer samples consistent with alcohol abstinence and non-heavy drinking days during the intervention and follow-up periods, 2) submit NNAL samples consistent with smoking abstinence and smoking reduction during intervention and follow-up periods, 3) Identify ANA-based mediators of treatment response across groups, and 4) Determine if biological sex interacts with treatment assignment to produce differential changes in our primary and secondary outcomes. If our hypotheses are borne out, this investigation may contribute to major health benefits for a prevalent and vastly underserved population. This could result in evidence-based telehealth interventions designed specifically to optimize care among heavy drinking smokers living in rural communities.





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