Disease Management for Smoking Cessation - Full Text View

Sponsors and Collaborators:	University of Kansas National Cancer Institute (NCI) GlaxoSmithKline
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00440115

Purpose

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.

Condition	Intervention	Phase
Smoking Cessation	Behavioral: High intensity disease management Behavioral: Low intensity disease management Other: Comparison group	Phase III

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Disease Management for Smokers in Rural Primary Care

Further study details as provided by University of Kansas:

Primary Outcome Measures:

7-day point prevalence abstinence from cigarettes [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of quit attempts [ Time Frame: 6, 12 18 and 24 months ] [ Designated as safety issue: No ]
Progress in stage of change [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	750
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental High intensity disease management	Behavioral: High intensity disease management Health education mailings, free nicotine replacement therapy or buproprion, 6 motivation interviews/counselling
2: Experimental Low intensity disease management	Behavioral: Low intensity disease management Health education mailings, free nicotine replacement therapy or buproprion, one motivation interview/counselling
3 Comparison group	Other: Comparison group Health education mailings, free nicotine replacement therapy or buproprion

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440115

Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

National Cancer Institute (NCI)

GlaxoSmithKline

Investigators

Principal Investigator:

Edward F. Ellerbeck, MD, MPH

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Edward Ellerbe )
Study ID Numbers:	5 R01 CA101963
Study First Received:	February 23, 2007
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00440115
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 14, 2009