Bio-Behavioral Lung Cancer Prevention Program

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00322205
First received: May 4, 2006
Last updated: May 18, 2006
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: zyban
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Bio-Behavioral Lung Cancer Prevention Program

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.

Secondary Outcome Measures:
  • Short-term quit rates using 7-day and 30-day point prevalence

Estimated Enrollment: 555
Study Start Date: June 1999
Estimated Study Completion Date: March 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Eligible smokers will be those currently smoking at least 10 cigarettes a day.

Exclusion Criteria:

Exclusionary criteria are: planning a pregnancy, pregnancy, lactating, seizure disorder, history of head trauma or prior seizure, family history of a seizure disorder, brain (or CNS) tumor, history of or currently diagnosed with bulimia or anorexia nervosa, diabetes treated with oral hypoglycemics or insulin, excessive use of alcohol or alcoholism, current addiction to opiates, cocaine, or stimulants, use of other drugs containing bupropion (e.g., Wellbutrin, Wellbutrin SR), allergy to bupropion, currently taking particular medications (e.g., monoamine oxidase inhibitor, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics), recently taken a MAOI (less than 14 days) or a recent discontinuation of a benzodiazepine.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00322205

Locations
United States, New York
State University of New York
Buffalo, New York, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Caryn Lerman University of Pennsylvania
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00322205     History of Changes
Obsolete Identifiers: NCT00326755
Other Study ID Numbers: 703463
Study First Received: May 4, 2006
Last Updated: May 18, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014