Phase 4
N=1,504
Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00332644 ↗Enrolled (actual)
1,504
Serious AEs
2.3%
Results posted
Nov 2011
Primary outcome: Primary: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed — 90; 87; 107; 84 participants with<10 ppm exhaled CO
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- nicotine patch (Drug); nicotine lozenge (Drug); nicotine patch + nicotine lozenge (Drug); bupropion (Drug); bupropion + lozenge (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed |
90; 87; 107; 84; 87; 42 | — |
Summary
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.
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
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 (NCT00332644). 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.