Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

February 26, 2018 updated by: University of Pennsylvania
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 eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Please see brief summary.

Study Type

Interventional

Enrollment (Actual)

568

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Tobacco Use Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 study.
  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Extended Patch Treatment
Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions.
Drug: 24-weeks of nicotine patch
24-weeks of 21mg nicotine patch
ACTIVE_COMPARATOR: Standard Patch Treatment
Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.
Drug: Standard Patch Treatment
8-weeks of nicotine patch + 16-weeks of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemically Verified 7-day Point Prevalence Abstinence
Time Frame: End of Treatment (week 24)
To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.
End of Treatment (week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 801851
  • P50CA084718 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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