Bio-Behavioral Lung Cancer Prevention Program
The overall goal of this research is to increase our understanding of the role of individual genetic differences in response to bupropion treatment and the psychobiological mechanisms by which genetic and treatment factors interact in the smoking cessation process. The ultimate objective is to provide information necessary to match bupropion vs. behavioral counseling cessation treatment to those smokers with the greatest need and likelihood of benefit. This study is a double-blind randomized placebo-controlled clinical trial of bupropion HCL (brand name Zyban) in adult male and female smokers. The factorial design includes one treatment factor (bupropion 300 mg/day + counseling vs. placebo + counseling) and several subject factors (e.g. genotype, personality). Smoking history, psychological status will be assessed at baseline and blood will be drawn for genotyping. Bupropion or placebo will be delivered over a 10-week treatment period and subjects will be instructed to quit smoking after two weeks of medication (week 3 of treatment). All subjects will also receive a 7-week group behavioral smoking cessation treatment (over an 11 week period). This study may yield information that will help clinicians identify the most effective smoking cessation treatment for a particular patient, based on his/her background.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Bio-Behavioral Lung Cancer Prevention Program|
- Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.
- Short-term quit rates using 7-day and 30-day point prevalence
|Study Start Date:||June 1999|
|Estimated Study Completion Date:||March 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322205
|United States, New York|
|State University of New York|
|Buffalo, New York, United States|
|Principal Investigator:||Caryn Lerman||University of Pennsylvania|