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. Identifier: NCT00296647
Recruitment Status : Completed
First Posted : February 27, 2006
Results First Posted : November 30, 2011
Last Update Posted : October 14, 2015
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

February 24, 2006
February 27, 2006
October 21, 2011
November 30, 2011
October 14, 2015
September 2004
July 2009   (Final data collection date for primary outcome measure)
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)
  • Smoking cessation
  • carbon monoxide (exhaled air)
Complete list of historical versions of study NCT00296647 on Archive Site
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Smoking Cessation Intervention: Effectiveness in Primary Care
Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tobacco Dependence
  • 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
  • Drug: nicotine lozenge
    4 mg nicotine lozenge: dosage according to package directions for 16 weeks
  • Drug: bupropion
    dosage according to prescription directions: 12 weeks
  • Drug: patch + lozenge
    dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
  • Drug: bupropion + lozenge
    dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)
  • Active Comparator: patch
    • Drug: nicotine patch
    • Drug: nicotine patch
  • Active Comparator: nicotine lozenge
    Intervention: Drug: nicotine lozenge
  • Active Comparator: bupropion
    Intervention: Drug: bupropion
  • Active Comparator: patch + lozenge
    Intervention: Drug: patch + lozenge
  • Active Comparator: buproion + lozenge
    Intervention: Drug: bupropion + lozenge

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P50DA019706 ( U.S. NIH Grant/Contract )
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Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Principal Investigator: Thomas C Jackson, MD Aurora Health Care
University of Wisconsin, Madison
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP