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Disease Management for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00440115
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
GlaxoSmithKline
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: High intensity disease management Behavioral: Low intensity disease management Behavioral: Comparison group Drug: Bupropion Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Disease Management for Smokers in Rural Primary Care
Study Start Date : June 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: High intensity disease management
High intensity disease management, free nicotine replacement therapy or bupropion
Behavioral: High intensity disease management
Health education mailings, 6 motivation interviews/counseling
Drug: Bupropion
Buproprion or Nicotine Replacement Therapy
Other Name: Nicotine Replacement Therapy
Experimental: Low intensity disease management
Low intensity disease management, free nicotine replacement therapy or bupropion
Behavioral: Low intensity disease management
Health education mailings, one motivation interview/counseling
Drug: Bupropion
Buproprion or Nicotine Replacement Therapy
Other Name: Nicotine Replacement Therapy
Comparison group
Comparison group, free nicotine replacement therapy or bupropion
Behavioral: Comparison group
Health education mailings
Drug: Bupropion
Buproprion or Nicotine Replacement Therapy
Other Name: Nicotine Replacement Therapy



Primary Outcome Measures :
  1. 7-day Point Prevalence Abstinence From Cigarettes [ Time Frame: 24 months ]
    Self-reported 7-day point prevalence abstinence from cigarettes


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440115


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Cancer Institute (NCI)
GlaxoSmithKline
Investigators
Principal Investigator: Edward F. Ellerbeck, MD, MPH University of Kansas Medical Center

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00440115     History of Changes
Other Study ID Numbers: 5R01CA101963 ( U.S. NIH Grant/Contract )
5R01CA101963 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2007    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors