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Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

Phase 3
18 Years
65 Years
Not Enrolling
Tobacco Use Cessation

Thank you

Trial Information

Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

Please see brief summary.

Inclusion Criteria:

1. Males and females of descent between the ages of 18-65 who smokes at least 10
cigarettes/day and are seeking smoking cessation treatment.

2. Based on the medical history, physical and laboratory examination, premenopausal
female subjects must consent to practice an effective form of contraception during

3. Following orientation by the research staff, subjects must sign written informed
consent for all study procedures.

Exclusion Criteria:

1. Women who are pregnant, planning a pregnancy, or lactating.

2. 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.

3. Current treatment of cancer or diagnosed with cancer in the past 6 months

4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine,
marijuana or stimulants, benzodiazepines).

5. Current use of TN or other forms of NRT.

6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within
past 14 days, antipsychotics, endogenous steroids, and antidepressants (including
wellbutrin or bupropion).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Biochemically Verified 7-day Point Prevalence Abstinence

Outcome Description:

To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.

Outcome Time Frame:

End of Treatment (week 24)

Safety Issue:


Principal Investigator

Caryn Lerman, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Institutional Review Board

Study ID:




Start Date:

June 2004

Completion Date:

May 2008

Related Keywords:

  • Tobacco Use Cessation



University of Pennsylvania Philadelphia, Pennsylvania  19104
Tobacco Use Research Center Philadelphia, Pennsylvania  19104