Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT) - Full Text View

Sponsors and Collaborators:	University of Pennsylvania National Institutes of Health (NIH)
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00326781

Purpose

The purpose of this research study is to:

compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and
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.

Condition	Intervention	Phase
Smoking	Drug: Transdermal Nicotine Drug: Nicotine nasal spray	Phase IV

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2

Further study details as provided by University of Pennsylvania:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment:	600
Study Start Date:	October 1998
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Active Comparator	Drug: Transdermal Nicotine 6 weeks of 21mg, 2 weeks of 14mg + 2 weeks of 7mg
2.: Active Comparator	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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326781

Sponsors and Collaborators

University of Pennsylvania

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Caryn Lerman, Ph.D.

University of Pennsylvania

More Information

Publications of 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.

Responsible Party:	University of Pennsylvania ( Caryn Lerman, Ph.D. )
Study ID Numbers:	703294
Study First Received:	May 15, 2006
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00326781
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Nicotine nasal spray + counseling
Transdermal nicotine + counseling

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009