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

NCT00326781 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 674

Last updated 2010-08-24

Study results available
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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).

Conditions

  • Smoking

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Caryn Lerman, Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-12-31
Primary Completion
2004-08-31
Completion
2004-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00326781 on ClinicalTrials.gov