Adaptive Treatment for Smoking Relapse (ADAPT Trial)

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help smokers who struggle to quit by providing free nicotine replacement therapies, varenicline, or e-cigarettes for 12 weeks. Participants will also have remote visits and assessments. After

Who is the study for?

This trial is for smokers who are eager to quit. It's not suitable for non-smokers or those who aren't looking to stop smoking.

What is being tested?

The study tests if changing treatments helps people struggling to quit smoking. Participants will use nicotine replacement, varenicline, or e-cigarettes and may switch between them based on their quitting progress.

What are the potential side effects?

Possible side effects include skin irritation from patches, sleep disturbances or mood changes with varenicline, and throat irritation or coughing from e-cigarette use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-responders after initial course of FDA-approved medication

Secondary study objectives

Dependence and duration of longest quit attempt

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Non-Adaptive Randomization 2Experimental Treatment1 Intervention

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.

Group II: Non-Adaptive Randomization 1Experimental Treatment1 Intervention

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

Group III: Harm Reduction Randomization 2Experimental Treatment1 Intervention

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

Group IV: Adaptive Randomization 1Experimental Treatment1 Intervention

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

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