Phase 4
N=1,346
Smoking Cessation Intervention: Effectiveness in Primary Care
Tobacco Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00296647 ↗Enrolled (actual)
1,346
Serious AEs
0.7%
Results posted
Nov 2011
Primary outcome: Primary: 6 Month Self-reported Abstinence From Smoking — 50; 52; 45; 75 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- nicotine patch (Drug); nicotine lozenge (Drug); bupropion (Drug); patch + lozenge (Drug); bupropion + lozenge (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Month Self-reported Abstinence From Smoking |
50; 52; 45; 75; 80 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00296647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.