Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

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.

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tobacco Use Research Center, Philadelphia, Pennsylvania, United States

About this study

Please see brief summary.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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).

Treatment and study plan

Standard Patch Treatment

Drug

8-weeks of nicotine patch + 16-weeks of placebo

24-weeks of nicotine patch

Drug

24-weeks of 21mg nicotine patch

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Aug 15, 2006
Registry last updated: Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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