- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00322205
Bio-behavioral Lung Cancer Prevention Program
Study Overview
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States
- State University of New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.
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Secondary Outcome Measures
Outcome Measure |
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Short-term quit rates using 7-day and 30-day point prevalence
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Collaborators and Investigators
Investigators
- Principal Investigator: Caryn Lerman, University of Pennsylvania
Publications and helpful links
General Publications
- Lerman C, Jepson C, Wileyto EP, Epstein LH, Rukstalis M, Patterson F, Kaufmann V, Restine S, Hawk L, Niaura R, Berrettini W. Role of functional genetic variation in the dopamine D2 receptor (DRD2) in response to bupropion and nicotine replacement therapy for tobacco dependence: results of two randomized clinical trials. Neuropsychopharmacology. 2006 Jan;31(1):231-42. doi: 10.1038/sj.npp.1300861.
- Wileyto EP, Patterson F, Niaura R, Epstein LH, Brown RA, Audrain-McGovern J, Hawk LW Jr, Lerman C. Recurrent event analysis of lapse and recovery in a smoking cessation clinical trial using bupropion. Nicotine Tob Res. 2005 Apr;7(2):257-68. doi: 10.1080/14622200500055673.
- Lerman C, Niaura R, Collins BN, Wileyto P, Audrain-McGovern J, Pinto A, Hawk L, Epstein LH. Effect of bupropion on depression symptoms in a smoking cessation clinical trial. Psychol Addict Behav. 2004 Dec;18(4):362-6. doi: 10.1037/0893-164X.18.4.362.
- Wileyto P, Patterson F, Niaura R, Epstein L, Brown R, Audrain-McGovern J, Hawk L, Lerman C, Patterson F. Do small lapses predict relapse to smoking behavior under bupropion treatment? Nicotine Tob Res. 2004 Apr;6(2):357-66. doi: 10.1080/1462220042000202463.
- Lerman C, Berrettini W, Pinto A, Patterson F, Crystal-Mansour S, Wileyto EP, Restine SL, Leonard DG, Shields PG, Epstein LH. Changes in food reward following smoking cessation: a pharmacogenetic investigation. Psychopharmacology (Berl). 2004 Aug;174(4):571-7. doi: 10.1007/s00213-004-1823-9. Epub 2004 Apr 27.
- Collins BN, Wileyto EP, Patterson F, Rukstalis M, Audrain-McGovern J, Kaufmann V, Pinto A, Hawk L, Niaura R, Epstein LH, Lerman C. Gender differences in smoking cessation in a placebo-controlled trial of bupropion with behavioral counseling. Nicotine Tob Res. 2004 Feb;6(1):27-37. doi: 10.1080/14622200310001656830.
- Lerman C, Shields PG, Wileyto EP, Audrain J, Pinto A, Hawk L, Krishnan S, Niaura R, Epstein L. Pharmacogenetic investigation of smoking cessation treatment. Pharmacogenetics. 2002 Nov;12(8):627-34. doi: 10.1097/00008571-200211000-00007.
- Lerman C, Roth D, Kaufmann V, Audrain J, Hawk L, Liu A, Niaura R, Epstein L. Mediating mechanisms for the impact of bupropion in smoking cessation treatment. Drug Alcohol Depend. 2002 Jul 1;67(2):219-23. doi: 10.1016/s0376-8716(02)00067-4.
- Ashare RL, Wileyto EP, Perkins KA, Schnoll RA. The first 7 days of a quit attempt predicts relapse: validation of a measure for screening medications for nicotine dependence. J Addict Med. 2013 Jul-Aug;7(4):249-54. doi: 10.1097/ADM.0b013e31829363e1.
- Javitz HS, Lerman C, Swan GE. Comparative dynamics of four smoking withdrawal symptom scales. Addiction. 2012 Aug;107(8):1501-11. doi: 10.1111/j.1360-0443.2012.03838.x. Epub 2012 Apr 17.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 703463
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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