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A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

NCT06118502 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2026-03-06

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2027-12-01
Completion
2028-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06118502 on ClinicalTrials.gov