A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

NCT ID: NCT06118502

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 544 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2028-03-31

Brief 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.

Detailed 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 either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.

Conditions

Cigarette Smoking; Smoking Behaviors; Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adaptive Randomization 1

This arm includes people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to medication will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again

Group Type: EXPERIMENTAL

Switching to a different medication

Intervention Type: 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.

Non-Adaptive Randomization 1

This arm includes people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again

Group Type: EXPERIMENTAL

Continued use of the same medication

Intervention Type: BEHAVIORAL

Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.

Harm Reduction Randomization 2

This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both). After two 4-week courses of pharmacotherapy, participants who are not responding to medication will be randomly assigned to a harm reduction group (e-cigarettes). Participants assigned to the harm reduction group will receive four weeks of e-cigarette product with instructions to switch completely

Group Type: EXPERIMENTAL

Switching to a harm reduction tobacco product

Intervention Type: BEHAVIORAL

Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8

Non-Adaptive Randomization 2

This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both sequentially). After two four-week courses of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again.

Group Type: EXPERIMENTAL

Continued use of the same medication

Intervention Type: BEHAVIORAL

Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.

Interventions

Switching 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.

Intervention Type: BEHAVIORAL

Continued 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.

Intervention Type: BEHAVIORAL

Switching to a harm reduction tobacco product

Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Smokers who want to quit

Exclusion Criteria

• Non-smokers

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Tracy Smith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tracy T Smith, PhD

Role: CONTACT

smithtra@musc.edu

8438725164

Matthew J Carpenter, PhD

Role: CONTACT

carpente@musc.edu

8438762436

Facility Contacts

William McCamy

Role: primary

mccamy@musc.edu

Other Identifiers

1R01CA284649-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00128175

Identifier Type: -

Identifier Source: org_study_id