A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

ConditionsCigarette Smoking Smoking Behaviors Treatment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Smokers who want to quit

Disqualifiers

Non-smokers

Trial design

Design model

Sequential

Treatments tested in this trial

Switching to a different medication
Behavioral
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.
Continued use of the same medication
Behavioral
Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.
Switching to a harm reduction tobacco product
Behavioral
Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8

Treatment groups

544 Participants

are divided into 4 treatment groups

Group A: Adaptive Randomization 1Experimental treatment 1 intervention

Group B: Non-Adaptive Randomization 1Experimental treatment 1 intervention

Group C: Harm Reduction Randomization 2Experimental treatment 1 intervention

Group D: Non-Adaptive Randomization 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Non-responders after initial course of FDA-approved medication

7-day point prevalence abstinence at Week 8 among non-responders at Week 4

Time frame

8 weeks

Secondary outcomes

Dependence and duration of longest quit attempt

7-day point prevalence abstinence at Week 12 among non-responders at Week 8.

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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