A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

NCT06118502 | Recruiting DMC

• 2 other identifiers: 001281751R01CA284649-01
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Non-responders after initial course of FDA-approved medication

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

  8 weeks

Secondary Outcomes (1)

• Dependence and duration of longest quit attempt

  12 weeks

Study Arms (4)

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

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

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

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.

Behavioral: Continued use of the same medication

Interventions

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.

Adaptive Randomization 1

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.

Non-Adaptive Randomization 1; Non-Adaptive Randomization 2

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

Harm Reduction Randomization 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers who want to quit

You may not qualify if:

• Non-smokers

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Central Study Contacts

Tracy T Smith, PhD

CONTACT

8438725164; smithtra@musc.edu

Matthew J Carpenter, PhD

CONTACT

8438762436; carpente@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: An Adaptive, Multi-Randomization Design

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)