Principal Investigator: Jed E. Rose
Funding Mechanism: National Institutes of Health - Grant
ID number: 1 R01 DA038554-01
Award Date: 2/10/2015
Institution: Duke University
E-cigarettes contain variable quantities of nicotine and non-nicotine tobacco alkaloids (NNTAs) (including anabasine, anatabine, nornicotine and myosmine), which are also present in conventional cigarettes. However, virtually no information is available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes (dual use); additionally, it is not known whether the presence of nicotine and NNTAs in e-cigarettes sustain dependence. This study will assess the effects of e-cigarette nicotine and NNTA content on 375 adult daily cigarette smokers (ages 18-65). Study aims are: (1) to assess the role of e-cigarette NNTA content in affecting dual use; (2) to assess the role of e-cigarette nicotine content in affecting dual use; and (3) to determine the relationship between dependence and systemic levels of nicotine and NNTAs. Participants will be randomized to one of three groups. Group 1 will use e-cigarettes that yield nicotine and NNTAs in the range of typical commercial cigarettes (e.g., 0.6 mg nicotine delivered in 10 puffs of 35 mL, with a ratio of NNTA to nicotine yield that is also typical of cigarettes). Group 2 will use e-cigarettes that contain minimal nicotine and NNTAs (less than 1/10 that of Group 1). Group 3 will use e-cigarettes that contain propylene glycol and extract from low nicotine/NNTA content tobacco (this group will control for changes in cigarette consumption that may occur due to study participation or to the non-nicotine behavioral/sensory factors associated with e-cigarette use, which could influence cigarette consumption). Dependence and dual use will be assessed according to: self-report diaries in which participants will track daily number of cigarettes smoked and number of occasions of e-cigarette use; cotinine concentrations and NNTA levels measured in urine, plasma, and saliva; various nicotine dependence, craving, and withdrawal measures; and tobacco abstinence after 12 weeks. Study findings may inform regulatory activities related to e-cigarettes.