A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
Medical University of South Carolina
Summary
This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each. All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.
Description
Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of ei…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Smokers who want to quit Exclusion Criteria: * Non-smokers
Interventions
- BehavioralSwitching to a different medication
Participants will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again at week 4.
- BehavioralContinued use of the same medication
Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.
- BehavioralSwitching to a harm reduction tobacco product
Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8
Location
- Medical University of South CarolinaCharleston, South Carolina