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Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364156
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : November 2, 2010
Last Update Posted : February 28, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Pennsylvania

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 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 or disease Intervention/treatment Phase
TOBACCO USE CESSATION Drug: Standard Patch Treatment Drug: 24-weeks of nicotine patch Phase 3

Detailed Description:
Please see brief summary.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Study Start Date : June 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364156

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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
National Cancer Institute (NCI)
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Principal Investigator: Caryn Lerman, Ph.D. University of Pennsylvania

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Pennsylvania Identifier: NCT00364156    
Other Study ID Numbers: 801851
P50CA084718 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2006    Key Record Dates
Results First Posted: November 2, 2010
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action