Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods
Medical University of South Carolina
Summary
This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.
Description
Even though e-cigarettes have risen in prevalence over the last decade, data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking. These data are urgently needed for several reasons. 1. Clinicians cannot provide clear guidance to smokers who may be interested in switching. Questions from medical patients about e-cigarettes are on the rise, and data show that medical providers are providing mixed messages about the safety and utility of e-cigarettes, with some physicians discouraging their use and some recommending them as cessation aids. 2.…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria * Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy. * Interest in reducing harms from tobacco use or quitting smoking Exclusion Criteria * Pregnant, breastfeeding, or trying to become pregnant. * Household member currently enrolled in the study * Planning to move out of the area within the next 7 months
Interventions
- BehavioralSwitching to E-Cigarette
Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date
- BehavioralSwitching using Medication
Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date
Location
- Medical Univeristy of South CarolinaCharleston, South Carolina