Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06118502

A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cigarette Smoking Behavior Smoking Smoking Behaviors Tobacco Smoking Tobacco Use Treatment

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

William McCamy

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Smokers who want to quit

Exclusion criteria

  • Non-smokers

Treatment and study plan

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

Primary outcomes

  1. Non-responders after initial course of FDA-approved medication

    Time frame: 8 weeks

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

Secondary outcomes

  1. Dependence and duration of longest quit attempt

    Time frame: 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew J Carpenter, PhD

CONTACT

[email protected]

8438762436

Tracy T Smith, PhD

CONTACT

[email protected]

8438725164

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: ADAPT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 7, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.