Recruiting

Adaptive Treatment

Sponsor:

Medical University of South Carolina

Code:

NCT06118502

Conditions

Cigarette Smoking

Smoking Behaviors

Treatment

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Switching to a different medication

Continued use of the same medication

Switching to a harm reduction tobacco product

Study Details

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.

Conditions

Cigarette Smoking

Smoking Behaviors

Treatment

Study ID

NCT06118502

Start date

Mar 25, 2024

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Smokers who want to quit

Exclusion Criteria:

  • Non-smokers

Study Design

Enrollment

544 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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

experimental: 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

experimental: 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.

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.

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.

Switching to a harm reduction tobacco product

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

Primary outcome measure

  • Non-responders after initial course of FDA-approved medication [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Tracy T Smith, PhD

8438725164smithtra@musc.edu

Matthew J Carpenter, PhD

8438762436carpente@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

William McCamy

mccamy@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.