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Behavioral Intervention

Non-Adaptive Randomization 2 for Smoking/Cigarette Smoking (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

ADAPT Trial 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.Check my eligibility

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.See study design

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.

ADAPT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Non-responders after initial course of FDA-approved medication

Secondary outcome measures

Dependence and duration of longest quit attempt

ADAPT 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,092 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,675 Previous Clinical Trials

40,926,433 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still eligible to apply for participation in this ongoing trial?

"Indeed, the details on clinicaltrials.gov highlight that this research is currently seeking suitable candidates. The trial was first made public on March 25th, 2024 and underwent its most recent update on March 27th, 2024. A total of 544 participants are sought from a single designated site for enrollment in this study."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"Indeed, clinicaltrials.gov data confirms the ongoing patient recruitment for this trial. The initial posting of the trial was on March 25th, 2024, with the latest update noted on March 27th, 2024. A total of 544 participants are sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

Tracy Smith 2024. "A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118502.

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