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

Phase 4

Completed

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).

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Nicotine Nasal Spray	Nicotine Nasal Spray	-
Transdermal Nicotine patch	Nicoderm Transdermal Patch	-

Primary Outcome Measures

Name	Time	Method
Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)	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

Name	Time	Method
Verified 7-day Point Prevalence Abstinence at End Of Treatment.	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.