Disease Management for Smoking Cessation

Phase 3

Completed

Conditions: Smoking Cessation

Interventions: Behavioral: Comparison group
Behavioral: High intensity disease management
Behavioral: Low intensity disease management
Drug: Bupropion

Registration Number: NCT00440115

Lead Sponsor: University of Kansas Medical Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 750

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity disease management	Bupropion	High intensity disease management, free nicotine replacement therapy or bupropion
Low intensity disease management	Bupropion	Low intensity disease management, free nicotine replacement therapy or bupropion
Comparison group	Comparison group	Comparison group, free nicotine replacement therapy or bupropion
High intensity disease management	High intensity disease management	High intensity disease management, free nicotine replacement therapy or bupropion
Low intensity disease management	Low intensity disease management	Low intensity disease management, free nicotine replacement therapy or bupropion
Comparison group	Bupropion	Comparison group, free nicotine replacement therapy or bupropion

Primary Outcome Measures

Name	Time	Method
7-day Point Prevalence Abstinence From Cigarettes	24 months	Self-reported 7-day point prevalence abstinence from cigarettes

Secondary Outcome Measures

Name	Time	Method
Progress in Stage of Change	6, 12, 18, 24 months	Progress in Stages of Change at 6, 12, 18, and 24 months
Number of Quit Attempts	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.