Clinical trial NCT01087905
Conditions: Smoking Smoking Cessation
Keywords: Smoking Smoking cessation Medication adherence
Sponsor: University of Wisconsin, Madison
Start date: 2010-04-01; Completion date: 2011-11-01
Enrollment: 987 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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.

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.

Arms: arm 1: 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 arm 2: 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 arm 3: 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. arm 4: 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. arm 5: 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 arm 6: 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 arm 7: 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. arm 8: 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.
Interventions: intervention 1: Nicotine patch intervention 2: Nicotine gum intervention 3: CMAC
Intervention descriptions: intervention 1: If \> 10 cigs/day: one 21 mg nicotine patch per day

If \< or = 10 cigs/day: one 14 mg nicotine patch per day intervention 2: 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 3: 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.

Protocol documents: