drugset / Trial / NCT00962988

Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease

NCT00962988

RandomizedParallel-groupOpen-labelPrevention

Summary

Research Aims The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy: 1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the long-term, compared to simply providing a prescription for these medications; 2. Is a more cost-effective alternative to providing a prescription only for these medications in this high risk population. Hypotheses to be Tested The hypotheses to be tested include the following: 1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy intervention group compared to the prescription only usual care group; 2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness (i.e., cost/quit) than providing a prescription only.

Timeline

Start
2009-12
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 150 mg
Subject Nicotine Unknown 7 mg Topical
Subject Nicotine Unknown 14 mg Topical
Subject Nicotine Unknown 21 mg Topical
Subject Varenicline Small molecule 1 mg