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

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ClinicalTrials.gov Identifier: NCT00326781
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : March 19, 2010
Last Update Posted : August 24, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Pennsylvania

Study Description
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Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Smoking Drug: Nicoderm Transdermal Patch Drug: Nicotine Nasal Spray Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 674 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 1999
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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 :
  1. Verified 7-day Point Prevalence Abstinence at End Of Treatment. [ Time Frame: End of Treatment ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326781


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Caryn Lerman, Ph.D. University of Pennsylvania
More Information
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Publications of Results:

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

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Responsible Party: Caryn Lerman, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00326781    
Other Study ID Numbers: 703294
P50CA084718 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2006    Key Record Dates
Results First Posted: March 19, 2010
Last Update Posted: August 24, 2010
Last Verified: March 2010
Keywords provided by University of Pennsylvania:
Nicotine nasal spray + counseling
Transdermal nicotine + counseling
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action