Bio-behavioral Lung Cancer Prevention Program

NCT ID: NCT00322205

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2002-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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zyban

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role lead

Principal Investigators

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Caryn Lerman

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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State University of New York

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16123753 (View on PubMed)

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.

Reference Type RESULT
PMID: 16036283 (View on PubMed)

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.

Reference Type RESULT
PMID: 15631608 (View on PubMed)

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.

Reference Type RESULT
PMID: 15203809 (View on PubMed)

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.

Reference Type RESULT
PMID: 15138759 (View on PubMed)

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.

Reference Type RESULT
PMID: 14982685 (View on PubMed)

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.

Reference Type RESULT
PMID: 12439223 (View on PubMed)

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.

Reference Type RESULT
PMID: 12095672 (View on PubMed)

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type DERIVED
PMID: 37230961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23669629 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22321019 (View on PubMed)

Other Identifiers

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703463

Identifier Type: -

Identifier Source: org_study_id

NCT00326755

Identifier Type: -

Identifier Source: nct_alias

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