Bio-Behavioral Lung Cancer Prevention Program
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
| 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 |
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 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 Smoking Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Habits |
ClinicalTrials.gov processed this record on May 16, 2013