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
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 or disease||Intervention/treatment||Phase|
|Smoking||Drug: Nicoderm Transdermal Patch Drug: Nicotine Nasal Spray||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||674 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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®
- 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.).
- 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.
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
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Caryn Lerman, Ph.D.||University of Pennsylvania|