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Smoking Cessation Interventions for Quitting Smoking

Phase 4
Waitlist Available
Led By Michael C Fiore, MD,MPH,MBA
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>17 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing different ways to get people who smoke to use treatments to help them quit, with the goal of reducing tobacco-related cancer morbidity and mortality.

Who is the study for?
This trial is for adult primary care patients who smoke daily, are not ready to quit yet, and can speak/read English. They must smoke at least five cigarettes a day for the past six months and have smoked every day in the week before joining. People with severe allergies or kidney disease that prevent them from using nicotine replacement therapy or varenicline, those with recent suicide attempts or current psychotic disorders, or who want to quit within 30 days are excluded.Check my eligibility
What is being tested?
The study tests whether financial incentives, tailored outreach materials, proactive calls from a tobacco care manager, and access to free smoking cessation counseling and medication help smokers start treatment. It's a complex experiment comparing different combinations of these methods over two years to see which helps more people stop smoking.See study design
What are the potential side effects?
Possible side effects may include skin irritation from nicotine patches; mouth issues like soreness with lozenges; nausea, sleep problems or mood changes with varenicline; plus potential stress related to quitting smoking such as irritability and cravings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 17 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who initiate treatment over 1 year of study enrollment
Number of participants who initiate treatment over 2 years of study enrollment
Secondary outcome measures
Number of participants who achieve biochemically verified seven-day point prevalence abstinence 2 years post-enrollment
Other outcome measures
First year intervention costs from healthcare and societal perspectives
Number of participants who complete intensive treatment
Number of participants who report short-term abstinence following smoking cessation treatment initiation
+1 more

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: No Incentive,Untailored,No Care Manage,IntensiveTreatmentExperimental Treatment4 Interventions
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group II: No Incentive,Untailored,Care Manage,Standard TreatmentExperimental Treatment4 Interventions
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Group III: No Incentive,Untailored,Care Manage,Intensive TreatmentExperimental Treatment5 Interventions
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group IV: No Incentive,Tailored,No Care Manage,Standard TreatmentExperimental Treatment3 Interventions
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Group V: No Incentive,Tailored,No Care Manage,Intensive TreatmentExperimental Treatment4 Interventions
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group VI: No Incentive,Tailored,Care Manage,Standard TreatmentExperimental Treatment4 Interventions
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Group VII: No Incentive,Tailored,Care Manage,Intensive TreatmentExperimental Treatment5 Interventions
Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group VIII: Incentive,Untailored,No Care Manage,Standard TreatmentExperimental Treatment4 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Group IX: Incentive,Untailored,No Care Manage,Intensive TreatmentExperimental Treatment5 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group X: Incentive,Untailored,Care Manage,Standard TreatmentExperimental Treatment5 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Group XI: Incentive,Untailored,Care Manage,Intensive TreatmentExperimental Treatment6 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group XII: Incentive,Tailored,No Care Manage,Standard TreatmentExperimental Treatment4 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Group XIII: Incentive,Tailored,No Care Manage,Intensive TreatmentExperimental Treatment5 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group XIV: Incentive,Tailored,Care Manage,Standard TreatmentExperimental Treatment5 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Group XV: Incentive,Tailored,Care Manage,Intensive TreatmentExperimental Treatment6 Interventions
Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.
Group XVI: No Incentive,Untailored,No Care Manage,Standard TreatmentActive Control3 Interventions
Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Care management
2012
N/A
~30

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,165,723 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,932,003 Total Patients Enrolled
Michael C Fiore, MD,MPH,MBAPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Care management Clinical Trial Eligibility Overview. Trial Name: NCT04199117 — Phase 4
Smoking/Cigarette Smoking Research Study Groups: Incentive,Tailored,Care Manage,Intensive Treatment, Incentive,Tailored,Care Manage,Standard Treatment, Incentive,Tailored,No Care Manage,Intensive Treatment, Incentive,Tailored,No Care Manage,Standard Treatment, Incentive,Untailored,Care Manage,Intensive Treatment, Incentive,Untailored,Care Manage,Standard Treatment, No Incentive,Untailored,Care Manage,Standard Treatment, Incentive,Untailored,No Care Manage,Intensive Treatment, Incentive,Untailored,No Care Manage,Standard Treatment, No Incentive,Tailored,Care Manage,Intensive Treatment, No Incentive,Tailored,No Care Manage,Intensive Treatment, No Incentive,Tailored,Care Manage,Standard Treatment, No Incentive,Tailored,No Care Manage,Standard Treatment, No Incentive,Untailored,Care Manage,Intensive Treatment, No Incentive,Untailored,No Care Manage,IntensiveTreatment, No Incentive,Untailored,No Care Manage,Standard Treatment
Smoking/Cigarette Smoking Clinical Trial 2023: Care management Highlights & Side Effects. Trial Name: NCT04199117 — Phase 4
Care management 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199117 — Phase 4

Frequently Asked Questions

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

What ailments does care management typically address?

"Care management has been proven to effectively address dry eye syndromes, nicotine addiction, and smoking-related illnesses."

Answered by AI

Are there any ongoing enrollment opportunities for this research study?

"This particular clinical trial, which was first posted on March 11th 2020 and last updated April 19th 2022, is not currently enrolling participants. Despite this, there are 268 other medical studies actively searching for volunteers at the present time."

Answered by AI

To what extent could Care management be detrimental to individuals?

"Care management is known to be a safe treatment and our team at Power gave it the highest rank of 3 in light of this being a Phase 4 trial, which indicates that it has already been approved."

Answered by AI

How many people have been enrolled in this medical experiment?

"At this time, no applicants are being sought for the study that was initially posted on March 11th 2020 and culminated its editing April 19th 2022. However, 181 trials related to smoking cigarettes are currently recruiting patients as well as 87 care management studies."

Answered by AI

Are there any further explorations into Care management that have already been undertaken?

"87 clinical trials are presently underway for care management, with 7 of those at the advanced phase 3 stage. The bulk of these research efforts can be found in Green Bay, Wisconsin, yet there are 259 distinct sites implementing this therapy."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What site did they apply to?
UW Center for Tobacco Research and Intervention
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Health Systems Reach Interventions Project
2020. "Health Systems Reach Interventions Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04199117.
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~327 spots leftby Apr 2025
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