Recruitment

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