Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00296647
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Completed
Phase Phase 4
Start date September 2004
Completion date December 2010

See also
  Status Clinical Trial Phase
Completed NCT01928719 - Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status N/A
Completed NCT01995123 - Behavioral Activation for Smoking Cessation in PTSD N/A
Not yet recruiting NCT03249428 - E-Cigarette Inner City RCT N/A
Recruiting NCT02564289 - Cardiovascular Effects of Chronic Snus Use N/A
Completed NCT01928758 - Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders N/A
Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT01428310 - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke Phase 1
Recruiting NCT00977249 - Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users Phase 2/Phase 3
Active, not recruiting NCT00968513 - Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry Phase 3
Completed NCT01113424 - Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum N/A
Completed NCT00722124 - S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence Phase 2/Phase 3
Completed NCT00747643 - Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement N/A
Completed NCT01228617 - Single-dose Pharmacokinetics of Oral Nicotine Replacement Products N/A
Completed NCT01238627 - Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg N/A
Completed NCT00394420 - Emergency Department Telephone Quitline N/A
Recruiting NCT05487807 - Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia Phase 1
Completed NCT03553992 - An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers N/A
Withdrawn NCT05440721 - Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification N/A
Completed NCT03694327 - Innovative Digital Therapeutic for Smoking Cessation N/A