A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06118502
Status
Recruiting
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Conditions

  • Cigarette Smoking
  • Smoking Behaviors
  • Treatment

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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

Study Details

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.

Key Dates

Start date
Mar 25, 2024
Status verified
Mar 2026
Primary completion
Dec 1, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
544 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Adaptive Randomization 1
    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
  • Experimental: Non-Adaptive Randomization 1
    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
  • Experimental: Harm Reduction Randomization 2
    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
  • Experimental: Non-Adaptive Randomization 2
    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.

Primary Outcome Measure

Non-responders after initial course of FDA-approved medication [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
William McCamy
[email protected]

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