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

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).

Condition	Intervention	Phase
Smoking	Drug: Nicoderm Transdermal Patch Drug: Nicotine Nasal Spray	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2

Resource links provided by NLM:

MedlinePlus related topics: Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) [ Time Frame: End of Treatment (8-weeks after quit date) ] [ Designated as safety issue: No ]
A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).

Secondary Outcome Measures:

Verified 7-day Point Prevalence Abstinence at End Of Treatment. [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey.

This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey.

Enrollment:	674
Study Start Date:	December 1999
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nicotine Nasal Spray	Drug: Nicotine Nasal Spray 8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks. Other Name: Nicotrol
Active Comparator: Transdermal Nicotine patch	Drug: Nicoderm Transdermal Patch The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks. Other Name: Nicoderm®

Arms

Assigned Interventions

Active Comparator: Nicotine Nasal Spray

Drug: Nicotine Nasal Spray

8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.

Other Name: Nicotrol

Active Comparator: Transdermal Nicotine patch

Drug: Nicoderm Transdermal Patch

The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.

Other Name: Nicoderm®

Detailed Description:

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.

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

Locations

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Caryn Lerman, Ph.D.

University of Pennsylvania

More Information

Publications:

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 publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Caryn Lerman, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00326781 History of Changes
Other Study ID Numbers:	703294, P50CA084718
Study First Received:	May 15, 2006
Results First Received:	May 15, 2009
Last Updated:	August 16, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Nicotine nasal spray + counseling
Transdermal nicotine + counseling

Additional relevant MeSH terms:

Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013