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UVM TCORS: Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Abusers

Principal Investigator: Stacey Sigmon

Funding Mechanism: National Institutes of Health- TCORS Grant

ID number: 1P50DA036114-01

Award Date: 9/30/2013

Institution: University of Vermont 

Reducing the nicotine content of cigarettes has shown promising beneficial effects (e.g., decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population, but studies have excluded vulnerable populations such as individuals with comorbid drug dependence, who may respond with compensatory increases in smoking rate or inhalation patterns, potentially increasing exposure and adverse health effects. Investigators will conduct two studies to evaluate the abuse liability and health effects of reduced nicotine content (RNC) cigarettes in 60 opioid-dependent smokers (aged 18-70) by comparing cigarettes varying in nicotine content across a range of doses starting from levels approximating those in normal nicotine content (NNC) cigarettes to low nicotine levels using brief- and extended-exposure protocols. Study 1 will evaluate the effects of brief exposure to RNC cigarettes among opioid-maintained smokers in the clinical laboratory under double-blind conditions, using a within-subjects design to examine the effects of RNC nicotine cigarettes on subjective measures (e.g., satisfaction, craving relief) and the extent to which the RNC cigarettes substitute for NNC cigarettes (0.80 mg) under conditions of varying constraints on the latter. Study 2 will evaluate the effects of extended exposure to RNC cigarettes in 400 opioid-maintained smokers using a between-subjects design that randomly assigns participants to one of four cigarette conditions (0.80, 0.26, 0.12 or 0.03 mg nicotine) for a 12-week period. Specific aims are: (1) to evaluate whether RNC cigarettes substitute for NNC cigarettes during brief exposure without producing compensatory increases in smoking, assessed by expired-breath carbon monoxide (CO); (2) to compare extended exposure to RNC and NNC cigarettes with regard to daily smoking rates (i.e., self-report, cotinine), tobacco smoke exposure levels (e.g., breath CO, urine cotinine), and nicotine dependence severity; (3) to assess adherence to assigned tobacco products and use of other nicotine products during the extended exposure conditions; (4) to quantify the effects of RNC cigarettes on biomarkers of exposure to tobacco carcinogens (e.g., cotinine, nitrosamine-4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL], polycyclic aromatic hydrocarbons [PAH]), markers of pulmonary and cardiovascular risk, and use of other non-prescribed drugs during extended exposure; and (5) to compare RNC and NNC cigarettes on abstinence-induced craving, withdrawal, cigarette demand and neurocognitive function. Data from this study may inform FDA policy decisions regarding reduced-nicotine tobacco products.

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