Disease Management for Smoking Cessation

University of Kansas

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Behavioral: High intensity disease management; Drug: Bupropion; Behavioral: Comparison group; Behavioral: Low intensity disease management

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00440115

5R01CA101963 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

High intensity disease management

Experimental group

Description:

High intensity disease management, free nicotine replacement therapy or bupropion

Treatment:

Drug: Bupropion

Behavioral: High intensity disease management

Low intensity disease management

Experimental group

Description:

Low intensity disease management, free nicotine replacement therapy or bupropion

Treatment:

Drug: Bupropion

Behavioral: Low intensity disease management

Comparison group

Other group

Description:

Comparison group, free nicotine replacement therapy or bupropion

Treatment:

Drug: Bupropion

Behavioral: Comparison group