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Smoking Cessation Intervention: Effectiveness in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00296647
Recruitment Status : Completed
First Posted : February 27, 2006
Results First Posted : November 30, 2011
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: nicotine patch Drug: nicotine lozenge Drug: bupropion Drug: patch + lozenge Drug: bupropion + lozenge Phase 4

Detailed Description:
Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Study Start Date : September 2004
Primary Completion Date : July 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: patch Drug: nicotine patch
Decreasing dosages from 21 to 7 mg over 12 week period
Drug: nicotine patch
Decreasing dosage from 21 to 7 mg over 12 weeks
Active Comparator: nicotine lozenge Drug: nicotine lozenge
4 mg nicotine lozenge: dosage according to package directions for 16 weeks
Active Comparator: bupropion Drug: bupropion
dosage according to prescription directions: 12 weeks
Active Comparator: patch + lozenge Drug: patch + lozenge
dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
Active Comparator: buproion + lozenge Drug: bupropion + lozenge
dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)


Outcome Measures

Primary Outcome Measures :
  1. 6 Month Self-reported Abstinence From Smoking [ Time Frame: 6 months ]
    Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)


Eligibility Criteria

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:   No
Criteria

Inclusion Criteria:

  • Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments, Aurora participating clinic patient

Exclusion Criteria:

  • Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
Contacts and Locations

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): NCT00296647


Locations
United States, Wisconsin
UW-CTRI Milwaukee Research site
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Thomas C Jackson, MD Aurora Health Care
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00296647     History of Changes
Obsolete Identifiers: NCT00106873
Other Study ID Numbers: H-2004-0462
P50DA019706 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2006    Key Record Dates
Results First Posted: November 30, 2011
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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