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Completed

NCT Number: NCT00440115

Disease Management for Smoking Cessation

The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease management and those receiving usual care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for nicotine dependence. In this study, we will recruit 750 smokers from 20 rural, primary care clinics in Kansas. Subjects will be randomly assigned to one of three study arms, each providing 20 months of treatment: C (comparison group), LDM (low-intensity disease management) or HDM (high-intensity disease management). Participants in group C will receive health educational mailings and an offer for free nicotine replacement therapy (six weeks) or bupropion (seven weeks) every 6 months (months 0, 6, 12, and 18). Participants in LDM will receive the same interventions as C plus a low-intensity disease management program that includes a single telephone counseling session using motivational interviewing (MI) at months 0, 6, 12, and 18 to encourage a cessation attempt and also includes coordination of smoking assessments and pharmacotherapy with the patient's physician. HDM participants will receive C plus a high intensity disease management program that includes up to six telephone-based MI counseling sessions at months 0, 6, 12, and 18 to encourage a smoking cessation attempt and to prevent relapse after a quit attempt, as well as coordination of smoking assessments, quit attempts, and pharmacotherapy with the patient's physician.

The primary outcome of the study is 7-day point prevalence abstinence from cigarettes at 2 years after enrollment. Secondary outcomes include: 1) number of quit attempts and 2) progress in stage of change. If successful, this intervention will provide a generalizable model for addressing nicotine dependence that could improve long-term management of smoking in primary care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over the age of 18
  • Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days
  • Speak English
  • Their regular physician is a participating physician
  • Working home telephone or cellular phone

Exclusion criteria

  • Women who are pregnant or planning to become pregnant in the next two years
  • Plan on moving within two years
  • Display signs of dementia or other mental disorders
  • Live with a smoker already enrolled

Treatment and study plan

High intensity disease management

Behavioral

Health education mailings, 6 motivation interviews/counseling

Low intensity disease management

Behavioral

Health education mailings, one motivation interview/counseling

Comparison group

Behavioral

Health education mailings

bupropion

Drug

Buproprion or Nicotine Replacement Therapy

Other names: Nicotine Replacement Therapy

Primary outcomes

  1. 7-day Point Prevalence Abstinence From Cigarettes

    Time frame: 24 months

    Self-reported 7-day point prevalence abstinence from cigarettes

Secondary outcomes

  1. Number of Quit Attempts

    Time frame: 6, 12, 18, 24 months

    Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.

  2. Progress in Stage of Change

    Time frame: 6, 12, 18, 24 months

    Progress in Stages of Change at 6, 12, 18, and 24 months

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • GlaxoSmithKline
  • National Cancer Institute (NCI)

Registry information

Official study title

Disease Management for Smokers in Rural Primary Care

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2007
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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