CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed
Drug / intervention
zybandrug
Likely dose
Not stated in record
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Search/NCT00322205
NCT00322205Phase 4Completed

Bio-behavioral Lung Cancer Prevention Program

National Institutes of Health (NIH)·interventional·Posted May 5, 2006·Updated Jan 11, 2017

In Brief

A Phase 4 clinical trial evaluating zyban for Smoking Cessation. Completed, across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2006
Enrollment StartJun 1, 1999
Study CompletionMar 1, 2002
TodayJul 2, 2026
Posted 20.2 years ago

Interventions

zybandrug