The purpose of this research study is to: 1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and 2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT). The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators...
Date First Received: May 15, 2006
Last Updated: March 28, 2008
Verified by: University of Pennsylvania, March 2008
Clinical Trial Phase: Phase 4 | Start Date: October 1998
Overall Status: Active, not recruiting
Estimated Enrollment: 600
Brief Summary
Official Title: “Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2”
Condition Keyword(s):
Intervention(s):
The purpose of this research study is to:
1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and
2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).
The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine nasal spray (NS) will result in significantly higher abstinence rates than transdermal nicotine (TN) for the following subgroups of smokers: those with genotypes associated with less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with higher levels of novelty-seeking, depression, and attention deficit symptoms.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: August 2004
Intervention(s) in this Clinical Trial
- Drug: Transdermal Nicotine
- 6 weeks of 21mg, 2 weeks of 14mg + 2 weeks of 7mg
- Drug: Nicotine nasal spray
- 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1.
- Active Comparator: 2.
Outcome Measures for this Clinical Trial
Primary Measures
- Primary measures of smoking cessation will be continuous abstinence at the end of treatment and 6- and 12-months post-target quit date.
- Time Frame: 12-months
Safety Issue?: No
- Time Frame: 12-months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- The subjects will be male and female smokers age 18-75.
- Eligible smokers will be those currently smoking at least 10 cigarettes a day.
Exclusion Criteria:
- Planning a pregnancy, pregnant, or lactating
- Current addiction to opiates, cocaine, or stimulants
- Skin allergies or chronic dermatitis (based on medical history/self-report)
- An Axis 1 major psychiatric disorder
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of Pennsylvania
Overall Clinical Trial Officials and Contacts
Caryn Lerman, Ph.D. Principal Investigator University of Pennsylvania
Related Publications
Citations Reporting Results
Munafo MR, Johnstone EC, Wileyto EP, Shields PG, Elliot KM, Lerman C. Lack of association of 5-HTTLPR genotype with smoking cessation in a nicotine replacement therapy randomized trial. Cancer Epidemiol Biomarkers Prev. 2006 Feb;15(2):398-400. No abstract available.
Malaiyandi V, Lerman C, Benowitz NL, Jepson C, Patterson F, Tyndale RF. Impact of CYP2A6 genotype on pretreatment smoking behaviour and nicotine levels from and usage of nicotine replacement therapy. Mol Psychiatry. 2006 Apr;11(4):400-9.
Dahl JP, Jepson C, Levenson R, Wileyto EP, Patterson F, Berrettini WH, Lerman C. Interaction between variation in the D2 dopamine receptor (DRD2) and the neuronal calcium sensor-1 (FREQ) genes in predicting response to nicotine replacement therapy for tobacco dependence. Pharmacogenomics J. 2006 Jan 10; [Epub ahead of print]
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.
Rukstalis M, Jepson C, Patterson F, Lerman C. Increases in hyperactive-impulsive symptoms predict relapse among smokers in nicotine replacement therapy. J Subst Abuse Treat. 2005 Jun;28(4):297-304.
Colilla S, Lerman C, Shields PG, Jepson C, Rukstalis M, Berlin J, DeMichele A, Bunin G, Strom BL, Rebbeck TR. Association of catechol-O-methyltransferase with smoking cessation in two independent studies of women. Pharmacogenet Genomics. 2005 Jun;15(6):393-8.
Strasser AA, Kaufmann V, Jepson C, Perkins KA, Pickworth WB, Wileyto EP, Rukstalis M, Audrain-McGovern J, Lerman C. Effects of different nicotine replacement therapies on postcessation psychological responses. Addict Behav. 2005 Jan;30(1):9-17.
Strasser AA, Pickworth WB, Patterson F, Lerman C. Smoking topography predicts abstinence following treatment with nicotine replacement therapy. Cancer Epidemiol Biomarkers Prev. 2004 Nov;13(11 Pt 1):1800-4.
Lerman C, Kaufmann V, Rukstalis M, Patterson F, Perkins K, Audrain-McGovern J, Benowitz N. Individualizing nicotine replacement therapy for the treatment of tobacco dependence: a randomized trial. Ann Intern Med. 2004 Mar 16;140(6):426-33.
Lerman C, Wileyto EP, Patterson F, Rukstalis M, Audrain-McGovern J, Restine S, Shields PG, Kaufmann V, Redden D, Benowitz N, Berrettini WH. The functional mu opioid receptor (OPRM1) Asn40Asp variant predicts short-term response to nicotine replacement therapy in a clinical trial. Pharmacogenomics J. 2004;4(3):184-92.
Patterson F, Jepson C, Kaufmann V, Rukstalis M, Audrain-McGovern J, Kucharski S, Lerman C. Predictors of attendance in a randomized clinical trial of nicotine replacement therapy with behavioral counseling. Drug Alcohol Depend. 2003 Nov 24;72(2):123-31. Erratum in: Drug Alcohol Depend. 2004 Mar 8;73(3):315.
Lerman C, Caporaso N, Main D, Audrain J, Boyd NR, Bowman ED, Shields PG. Depression and self-medication with nicotine: the modifying influence of the dopamine D4 receptor gene. Health Psychol. 1998 Jan;17(1):56-62.
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00326781
Study ID Number: 703294
ClinicalTrials.gov Identifier: NCT00326781
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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