Switch or Quit R01
Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods
Medical University of South Carolina
225 participants
Jul 10, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy.
- Interest in reducing harms from tobacco use or quitting smoking
Exclusion Criteria3
- 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
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Interventions
Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date
Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06373679