Actively Recruiting
A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
Led by Medical University of South Carolina · Updated on 2026-03-06
544
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether treatment decision-making can be improved for smokers who have difficulty quitting with medications. This trial focuses on smokers seeking to quit and evaluates adaptive treatment strategies using FDA-approved options. The goal is to find the best approach for each person by adjusting the treatment based on early response to medications. The study is sponsored by the Medical University of South Carolina and is designed as a randomized clinical trial without masking. Participants will receive a free 12-week course of nicotine replacement therapies (patches and lozenges), varenicline, or e-cigarettes as harm reduction products. Initially, smokers are randomized to either varenicline or combination NRT for four weeks. Those showing early success continue the same medication, while non-responders may switch to the other medication or continue the same one, with further adjustments made at weeks 4 and 8. After 12 weeks, no more products are provided. All study visits and assessments are conducted remotely through phone calls and surveys. Participants will complete eight surveys over six months, including a follow-up survey six months after the initial call. Researchers will measure smoking cessation success and dependence outcomes, with primary outcomes assessed at 8 weeks and final outcomes at 24 weeks. The study allows for safety monitoring throughout and involves no in-person visits.
CONDITIONS
Brief Title
A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Smokers who want to quit
- Adults aged 21 years and older
- Willing to use smoking cessation medications or products
- Able to participate in remote visits and surveys
You will not qualify if you...
- Non-smokers
- Under 21 years of age
- Not interested in quitting smoking
- Unable to participate in remote study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
Duration - 4 weeks
Participants receive a 4-week course of either varenicline or combination nicotine replacement therapy (NRT).
1 baseline visit and 1 follow-up visit
Duration - 8 weeks
Based on early treatment success at 4 weeks, participants either continue the same medication for another 4 weeks or switch to the other FDA-approved option. This adaptive process repeats at Week 8, with non-responders potentially switching to e-cigarettes for 4 weeks.
2 follow-up visits at Weeks 4 and 8
Duration - 12 weeks
After the 12-week treatment period, participants are followed up until Week 24 to assess smoking cessation outcomes and other secondary measures.
1 follow-up visit at Week 24
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
T
Tracy T Smith, PhD
M
Matthew J Carpenter, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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