Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2
Overview
- Phase
- Phase 4
- Intervention
- Nicotine Nasal Spray
- Conditions
- Smoking
- Sponsor
- University of Pennsylvania
- Enrollment
- 674
- Locations
- 1
- Primary Endpoint
- Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subjects will be male and female smokers age 18-
- •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
Arms & Interventions
Nicotine Nasal Spray
Intervention: Nicotine Nasal Spray
Transdermal Nicotine patch
Intervention: Nicoderm Transdermal Patch
Outcomes
Primary Outcomes
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 Outcomes
- Verified 7-day Point Prevalence Abstinence at End Of Treatment.(End of Treatment)