Bio-behavioral Lung Cancer Prevention Program

NCT00322205 | Completed Phase 4

• 1 other identifier: 703463
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Short-term quit rates using 7-day and 30-day point prevalence

Interventions

zyban DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National Institutes of Health (NIH): lead

Study Sites (1)

State University of New York

Buffalo, New York, United States

Location

Related Publications (11)

• 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.

  PMID: 16123753 RESULT

• 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.

  PMID: 16036283 RESULT

• 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.

  PMID: 15631608 RESULT

• 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.

  PMID: 15203809 RESULT

• 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.

  PMID: 15138759 RESULT

• 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.

  PMID: 14982685 RESULT

• 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.

  PMID: 12439223 RESULT

• 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.

  PMID: 12095672 RESULT

• 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.

  PMID: 37230961 DERIVED

• 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.

  PMID: 23669629 DERIVED

• 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.

  PMID: 22321019 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Caryn Lerman

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 4, 2006
• First Posted: May 5, 2006
• Study Start: June 1, 1999
• Study Completion: March 1, 2002
• Last Updated: January 11, 2017

Record last verified: 2006-05

Locations

US (1)