Cigarette SmokingADAPTNCT06118502
A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
A study testing Switching to a different medication, Continued use of the same medication and Switching to a harm reduction tobacco product in people with Cigarette Smoking and Smoking Behaviors, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Smoking Behaviors, Treatment
- What is being tested?
- Switching to a different medication, Continued use of the same medication and Switching to a harm reduction tobacco product
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to 31 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokers who want to quit
Who cannot join
- Non-smokers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
William McCamy, mccamy@musc.edu
About this study
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.
Read the 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
- Being tested
- Switching to a different medication, Continued use of the same medication, Switching to a harm reduction tobacco product
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switching to a different medicationBehavioural
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 medicationBehavioural
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 productBehavioural
Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Randomization 1 | Experimental | 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 Receives: Behavioral: Switching to a different medication |
| Non-Adaptive Randomization 1 | Experimental | 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 Receives: Behavioral: Continued use of the same medication |
| Harm Reduction Randomization 2 | Experimental | 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 Receives: Behavioral: Switching to a harm reduction tobacco product |
| Non-Adaptive Randomization 2 | Experimental | 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. Receives: Behavioral: Continued use of the same medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-responders after initial course of FDA-approved medication
7-day point prevalence abstinence at Week 8 among non-responders at Week 4
Measured: 8 weeks
Secondary outcomes (1)
Dependence and duration of longest quit attempt
7-day point prevalence abstinence at Week 12 among non-responders at Week 8.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start25 Mar 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- An Adaptive, Multi-Randomization Design
- Masking
- None (open label)
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Tracy Smith, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118502
- Sponsor's protocol ID
- 00128175
- Other IDs
- 1R01CA284649-01
- Acronym
- ADAPT
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No