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Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00364156
First received: August 14, 2006
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Tobacco Use Cessation
Drug: Standard Patch Treatment
Drug: 24-weeks of nicotine patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Biochemically Verified 7-day Point Prevalence Abstinence [ Time Frame: End of Treatment (week 24) ] [ Designated as safety issue: No ]
    To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.


Enrollment: 568
Study Start Date: June 2004
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Please see brief summary.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364156

Locations
United States, Pennsylvania
Tobacco Use Research Center
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Caryn Lerman, Ph.D. University of Pennsylvania
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Caryn Lerman, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00364156     History of Changes
Other Study ID Numbers: 801851, P50CA084718
Study First Received: August 14, 2006
Results First Received: October 6, 2010
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014