Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
2 other identifiers
interventional
987
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
April 24, 2013
CompletedDecember 8, 2016
October 1, 2016
10 months
March 15, 2010
January 30, 2013
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
7-Day Point Prevalence Abstinence From Smoking by Intervention
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
26 weeks after the target quit smoking date
7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
26 weeks after the target quit smoking date
Secondary Outcomes (1)
Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
26 weeks after the target quit smoking date
Study Arms (8)
2 Weeks of Nicotine Patch Only, No CMAC
ACTIVE COMPARATORParticipants 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
2 Weeks of Nicotine Patch Only plus CMAC
ACTIVE COMPARATORParticipants 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
2 Wks Nicotine Patch+Nic Gum, No CMAC
ACTIVE COMPARATORParticipants 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.
2 Wks Nicotine Patch+Nic Gum plus CMAC
ACTIVE COMPARATORParticipants 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.
6 Weeks of Nicotine Patch Only, No CMAC
ACTIVE COMPARATORParticipants 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
6 Weeks of Nicotine Patch Only plus CMAC
ACTIVE COMPARATORParticipants 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
6 Wks Nicotine Patch+Nic Gum, No CMAC
ACTIVE COMPARATORParticipants 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.
6 Wks Nicotine Patch+Nic Gum plus CMAC
ACTIVE COMPARATORParticipants 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.
Interventions
If \> 10 cigs/day: one 21 mg nicotine patch per day If \< or = 10 cigs/day: one 14 mg nicotine patch per day
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 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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Wisconsin Department of Health and Family Servicescollaborator
- Consumer Wellness Solutionscollaborator
- Department of Health and Human Servicescollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
Seattle, Washington, 98104, United States
University of Wisconsin Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711, United States
Related Publications (1)
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.
PMID: 22992296RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stevens S. Smith, Ph.D.
- Organization
- University of Wisconsin School of Medicine and Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Stevens S Smith, PhD
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
- STUDY DIRECTOR
Paula A Keller, MPH
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2010
First Posted
March 16, 2010
Study Start
April 1, 2010
Primary Completion
February 1, 2011
Study Completion
November 1, 2011
Last Updated
December 8, 2016
Results First Posted
April 24, 2013
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Upon request, clinical trial data will be shared with other investigators in the form of de-identified datasets. Requests can be sent to Stevens S. Smith, Ph.D., at sss@ctri.wisc.edu