Your session is about to expire
← Back to Search
Behavioral Intervention
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
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
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
977 Previous Clinical Trials
7,400,373 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,955 Previous Clinical Trials
41,111,417 Total Patients Enrolled