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

NCT01087905 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 987

Last updated 2016-12-08

Study results available
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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.

Conditions

  • Smoking
  • Smoking Cessation

Interventions

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.

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.

Sponsors & Collaborators

  • Wisconsin Department of Health and Family Services

    collaborator OTHER_GOV
  • Consumer Wellness Solutions

    collaborator INDUSTRY
  • Department of Health and Human Services

    collaborator FED
  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Stevens S Smith, PhD · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

  • Paula A Keller, MPH · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-02-28
Completion
2011-11-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087905 on ClinicalTrials.gov