Principal Investigator(s): Stacey C. Sigmon
Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036114-06
Award Date: 8/31/18
Institution: University of Vermont and State Agricultural College
Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. Smoking is also associated with significant morbidity and mortality in this population, with the mortality rate of opioid-dependent smokers four times that of opioid-dependent nonsmokers and quit rates of approximately one-fourth that of non-substance abusers. Research indicates that smokers with OUD respond to very low nicotine content cigarettes (VLNCCs) with reductions in cigarette demand and other measures of addiction potential. The goal of this project is to evaluate whether increased availability and appeal of an alternative non-combusted nicotine source (e-cigarettes) will enhance the effectiveness of a reduced-nicotine standard for cigarettes in smokers with current OUD. Study aims are: (1) to compare the effects of normal nicotine content cigarettes (NNCCs) alone, VLNCCs alone, VLNCCs + tobacco-flavored e-cigarettes, and VLNCCs + preferred-flavor e-cigarettes on total number of cigarettes per day; (2) to compare the effects of the four study conditions on cigarette demand, smoke exposure (breath carbon monoxide), and tobacco carcinogen biomarkers (NNAL, PAH metabolites); (3) to explore the effects of the four study conditions on cerebral blood flow, other measures of brain function and structure, and airway inflammation; and (4) to explore the effects of the four study conditions on abstinence-induced cigarette demand, craving, and withdrawal. In this study, 300 adults with OUD (ages 18-70) will be randomized to 16 weeks of exposure to (1) normal nicotine content cigarettes alone, which will serve as the control condition, (2) VLNC cigarettes alone, (3) VLNCs + tobacco-flavored nicotinized e-cigarettes, or (4) VLNCs + nicotinized e-cigarette with preferred flavoring. Participants will complete two in-person assessments (involving baseline health and smoking assessments, a variety of questionnaires, biomarker assessments, cognitive functioning tests, and functional MRI) and use an interactive voice response system to report daily product use and nicotine withdrawal symptoms. After 16 weeks of use, participants will undergo an abstinence assessment in which researchers will examine the effects of the study conditions on participants’ ability to abstain from cigarettes and their responses to abstinence. Findings may inform regulatory activities related to reduced-nicotine cigarettes.
UVM TCORS: University of Vermont Tobacco Center of Regulatory Science Related Resources
- UVM TCORS: University of Vermont Tobacco Center of Regulatory Science
- UVM TCORS Project 1: Low Nicotine Content Cigarettes in Vulnerable Populations: Economically Disadvantaged Women (Non-Pregnant)
- UVM TCORS Project 3: Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders
- UVM TCORS Project 4: Low Nicotine Content Cigarettes in Vulnerable Populations: Pregnant Women
- The original scientific abstract and other project information can be found on the NIH website.