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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

Must not have

Current treatment for schizophrenia or a psychotic disorder at enrollment

Willing to quit smoking within 30 days (these patients will be referred for immediate treatment rather than enrolled in this study)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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

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I am older than 17 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for schizophrenia or a psychotic disorder.

Select...

I am willing to quit smoking within 30 days.

Select...

I cannot use certain smoking cessation aids due to allergies or severe kidney disease.

Select...

I chose not to participate in Care Manager outreach recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary study objectives

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 study objectives

Number of participants who achieve biochemically verified seven-day point prevalence abstinence 2 years post-enrollment

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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