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Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

NCT ID: NCT01087905

Last Updated: 2016-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

987 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-11-30

Brief Summary

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Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.

Detailed Description

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The study design is a fully crossed 2x2x2 factorial design that tested the effect of two versus six weeks of nicotine replacement therapy (NRT), the effect of NRT monotherapy (nicotine patch alone) versus NRT combination therapy (nicotine patch + oral NRT), and the effect of cognitive medication adherence counseling (CMAC) versus no CMAC. A total of 987 smokers seeking cessation assistance from the Wisconsin Tobacco Quit Line (WTQL) were randomly assigned to the eight (2x2x2) different conditions generated by the three experimental factors. This design provides us with sufficient power to analyze each of our three main effects listed above. We will also test for two- and three-way interactions, but do not have sufficient data to make a priori assumptions about interaction effects. Finally, we will conduct a cost-effectiveness analysis for each of the three interventions to allow readers of this research to evaluate whether the additional costs of the interventions yield sufficient gains to warrant implementing them broadly.

Conditions

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Smoking Smoking Cessation

Keywords

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Smoking Smoking cessation Medication adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2 Weeks of Nicotine Patch Only, No CMAC

Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

2 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

2 Weeks of Nicotine Patch Only plus CMAC

Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling

2 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

CMAC

Intervention Type BEHAVIORAL

CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.

2 Wks Nicotine Patch+Nic Gum, No CMAC

Participants in this randomization arm received 2 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

2 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks

2 Weeks of Nicotine gum dosed as follows:

If \< 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

Nicotine gum

Intervention Type DRUG

If \< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

2 Wks Nicotine Patch+Nic Gum plus CMAC

Participants in this randomization arm received 2 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling

2 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks

2 Weeks of Nicotine gum dosed as follows:

If \< 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

Nicotine gum

Intervention Type DRUG

If \< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

CMAC

Intervention Type BEHAVIORAL

CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.

6 Weeks of Nicotine Patch Only, No CMAC

Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

6 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

6 Weeks of Nicotine Patch Only plus CMAC

Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling

6 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

CMAC

Intervention Type BEHAVIORAL

CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.

6 Wks Nicotine Patch+Nic Gum, No CMAC

Participants in this randomization arm received 6 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

6 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks

6 Weeks of Nicotine gum dosed as follows:

If \< 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

Nicotine gum

Intervention Type DRUG

If \< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

6 Wks Nicotine Patch+Nic Gum plus CMAC

Participants in this randomization arm received 6 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling

6 Weeks of Nicotine patch dosed as follows:

If \> 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If \< or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks

6 Weeks of Nicotine gum dosed as follows:

If \< 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

Nicotine gum

Intervention Type DRUG

If \< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

CMAC

Intervention Type BEHAVIORAL

CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.

Interventions

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Nicotine patch

If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day

Intervention Type DRUG

Nicotine gum

If \< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Intervention Type DRUG

CMAC

CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.

Intervention Type BEHAVIORAL

Other Intervention Names

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Nicotine polacrilex Cognitive Medication Adherence Counseling

Eligibility Criteria

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Inclusion Criteria

* Callers will be eligible to participate in the study if they are English speaking; are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are interested in quitting and are willing to set a quit date; willing and able to use nicotine patch and nicotine gum; agree to receive four follow-up counseling calls from Free \& Clear (the quitline vendor for the State of Wisconsin); provide verbal informed consent; and provide contact information and agree to take four study follow-up calls from staff at the University of Wisconsin Center for Tobacco Research and Intervention.

Exclusion Criteria

* Callers will be excluded if they are under the age of 18; are pregnant or breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are unwilling or unable to use study NRT medications; are currently using a cessation medication (NRT, bupropion, varenicline); or have medical exclusions as per FDA-approved product labeling.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wisconsin Department of Health and Family Services

OTHER_GOV

Sponsor Role collaborator

Consumer Wellness Solutions

INDUSTRY

Sponsor Role collaborator

Department of Health and Human Services

FED

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stevens S Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Paula A Keller, MPH

Role: STUDY_DIRECTOR

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Locations

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Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)

Seattle, Washington, United States

Site Status

University of Wisconsin Center for Tobacco Research and Intervention

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res. 2013 Mar;15(3):718-28. doi: 10.1093/ntr/nts186. Epub 2012 Sep 19.

Reference Type RESULT
PMID: 22992296 (View on PubMed)

Related Links

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http://www.ctri.wisc.edu/

University of Wisconsin Center for Tobacco Research and Intervention

Other Identifiers

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1RC1CA144382-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H2009-0074

Identifier Type: -

Identifier Source: org_study_id