The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 375
Summary
- Conditions
- Nicotine Dependence
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Both males and females
Description
A single group of thirty smokers will be recruited for the study to provide initial data to inform follow-up randomized controlled trials. Dependence and concurrent use of e-cigarettes and cigarettes will be assessed by a battery of self-report, biochemical, and behavioral indices. This is not a tob...
A single group of thirty smokers will be recruited for the study to provide initial data to inform follow-up randomized controlled trials. Dependence and concurrent use of e-cigarettes and cigarettes will be assessed by a battery of self-report, biochemical, and behavioral indices. This is not a tobacco cessation study and there is no intent to use e-cigarettes as a smoking cessation treatment. Smokers will be asked to use the e-cigarettes instead of their regular cigarettes during the study. E-cigarettes will not be used for the purpose of reducing urges, withdrawal or nicotine dependence; and e-cigarettes will not be described or used as a medical device or therapy. Specific Aim 1: To assess the extent of switching from combustible cigarettes to e-cigarettes delivering nicotine along with NNTAs. Switching will be assessed by self-report diaries and by reductions in expired air carbon monoxide, an index of combustible cigarette use. Specific Aim 2: To assess the acceptability of e-cigarettes delivering nicotine along with NNTAs. Ratings of user satisfaction and other subjective effects will be collected from participants, for both their customary brand of cigarettes and the e-cigarette to be used. Specific Aim 3: To determine the extent of dependence maintained during use of e-cigarettes delivering nicotine with NNTAs, as well as the relationship between dependence and self-reported use of cigarettes and e-cigarettes.
Tracking Information
- NCT #
- NCT02590393
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Principal Investigator: Jed Rose, Ph.D. Duke University