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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2

Conditions
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Smoking

Intervention / Treatment
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* Drug: Nicoderm Transdermal Patch
* Drug: Nicotine Nasal Spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine Nasal Spray<br> | Drug: Nicotine Nasal Spray<br>* 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.<br>* Other names: Nicotrol;|
| Active Comparator: Transdermal Nicotine patch<br> | Drug: Nicoderm Transdermal Patch<br>* 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.<br>* Other names: Nicoderm®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | 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.). | End of Treatment (8-weeks after quit date) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verified 7-day Point Prevalence Abstinence at 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. | End of Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine nasal spray + counseling, Transdermal nicotine + counseling