Status:
COMPLETED
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
TOBACCO USE CESSATION
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibil...
Detailed Description
Please see brief summary.
Eligibility Criteria
Inclusion
- Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment.
- Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study.
- Following orientation by the research staff, subjects must sign written informed consent for all study procedures.
Exclusion
- Women who are pregnant, planning a pregnancy, or lactating.
- Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes.
- Current treatment of cancer or diagnosed with cancer in the past 6 months
- Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines).
- Current use of TN or other forms of NRT.
- Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
568 Patients enrolled
Trial Details
Trial ID
NCT00364156
Start Date
June 1 2004
End Date
May 1 2008
Last Update
February 28 2018
Active Locations (2)
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1
Tobacco Use Research Center
Philadelphia, Pennsylvania, United States, 19104
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104