Clinical trial NCT00322205: Bio-behavioral Lung Cancer Prevention Program
Official title: Bio-behavioral Lung Cancer Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2006-05-05
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.
Secondary outcomes:
measure: Short-term quit rates using 7-day and 30-day point prevalence
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York
state: New York
Study officials:
affiliation: University of Pennsylvania
name: Caryn Lerman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.