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

• ClinicalTrials.gov Identifier: NCT01087905
• Recruitment Status: Completed
• First Posted: March 16, 2010
• Results First Posted: April 24, 2013
• Last Update Posted: December 8, 2016
• Sponsor: University of Wisconsin, Madison
• Collaborators: Wisconsin Department of Health and Family Services; Consumer Wellness Solutions; Department of Health and Human Services; National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking; Smoking Cessation	Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: CMAC	Phase 4

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 987 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
• Study Start Date: April 2010
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	Drug: 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
Active Comparator: 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	Drug: 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; Behavioral: 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.; Other Name: Cognitive Medication Adherence Counseling
Active Comparator: 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.	Drug: 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; 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.; Other Name: Nicotine polacrilex
Active Comparator: 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.	Drug: 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; 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.; Other Name: Nicotine polacrilex; Behavioral: 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.; Other Name: Cognitive Medication Adherence Counseling
Active Comparator: 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	Drug: 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
Active Comparator: 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	Drug: 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; Behavioral: 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.; Other Name: Cognitive Medication Adherence Counseling
Active Comparator: 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.	Drug: 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; 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.; Other Name: Nicotine polacrilex
Active Comparator: 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.	Drug: 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; 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.; Other Name: Nicotine polacrilex; Behavioral: 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.; Other Name: Cognitive Medication Adherence Counseling

Outcome Measures

Primary Outcome Measures :

1. 7-Day Point Prevalence Abstinence From Smoking by Intervention [ Time Frame: 26 weeks after the target quit smoking date ]
   Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
2. 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group [ Time Frame: 26 weeks after the target quit smoking date ]
   Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.

Secondary Outcome Measures :

1. Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group [ Time Frame: 26 weeks after the target quit smoking date ]
   For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

The only people eligible for this study are Wisconsin residents who contact the Wisconsin Tobacco Quit Line for smoking cessation services.

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.

Contacts and Locations

Locations

United States, Washington

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

Seattle, Washington, United States, 98104

United States, Wisconsin

University of Wisconsin Center for Tobacco Research and Intervention

Madison, Wisconsin, United States, 53711

Sponsors and Collaborators

University of Wisconsin, Madison

Wisconsin Department of Health and Family Services

Consumer Wellness Solutions

Department of Health and Human Services

National Cancer Institute (NCI)

Investigators

• 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

More Information

Additional Information:

University of Wisconsin Center for Tobacco Research and Intervention 

Publications of Results:

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.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01087905
• Other Study ID Numbers: H2009-0074; 1RC1CA144382-01 ( U.S. NIH Grant/Contract )
• First Posted: March 16, 2010
• Results First Posted: April 24, 2013
• Last Update Posted: December 8, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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

Keywords provided by University of Wisconsin, Madison:

Smoking; Smoking cessation; Medication adherence

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action