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Completed

NCT Number: NCT00326781

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

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).

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Key information

Conditions

Smoking Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicoderm Transdermal Patch

Drug

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 names: Nicoderm®

Nicotine Nasal Spray

Drug

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 names: Nicotrol

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
May 17, 2006
Registry last updated
Aug 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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