Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

TOBACCO USE CESSATION Clinical Trial

Official title:

Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364156
• Other study ID #: 801851
• Secondary ID: P50CA084718
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2006
• Last updated: February 26, 2018
• Start date: June 2004
• Est. completion date: May 2008

Study information

• Verified date: February 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please see brief summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• TOBACCO USE CESSATION

Intervention

Drug:
• Standard Patch Treatment
8-weeks of nicotine patch + 16-weeks of placebo
• 24-weeks of nicotine patch
24-weeks of 21mg nicotine patch

Locations

Country	Name	City	State
United States	Tobacco Use Research Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Lerman C, Jepson C, Wileyto EP, Patterson F, Schnoll R, Mroziewicz M, Benowitz N, Tyndale RF. Genetic variation in nicotine metabolism predicts the efficacy of extended-duration transdermal nicotine therapy. Clin Pharmacol Ther. 2010 May;87(5):553-7. doi: — View Citation

Patterson F, Kerrin K, Wileyto EP, Lerman C. Increase in anger symptoms after smoking cessation predicts relapse. Drug Alcohol Depend. 2008 May 1;95(1-2):173-6. doi: 10.1016/j.drugalcdep.2008.01.013. Epub 2008 Mar 6. — View Citation

Ray R, Mitra N, Baldwin D, Guo M, Patterson F, Heitjan DF, Jepson C, Wileyto EP, Wei J, Payne T, Ma JZ, Li MD, Lerman C. Convergent evidence that choline acetyltransferase gene variation is associated with prospective smoking cessation and nicotine depend — View Citation

Schnoll RA, Patterson F, Wileyto EP, Heitjan DF, Shields AE, Asch DA, Lerman C. Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Ann Intern Med. 2010 Feb 2;152(3):144-51. doi: 10.7326/0003-4819-152-3-201002020-00005. — View Citation

Schnoll RA, Patterson F, Wileyto EP, Tyndale RF, Benowitz N, Lerman C. Nicotine metabolic rate predicts successful smoking cessation with transdermal nicotine: a validation study. Pharmacol Biochem Behav. 2009 Mar;92(1):6-11. doi: 10.1016/j.pbb.2008.10.01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically Verified 7-day Point Prevalence Abstinence	To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.	End of Treatment (week 24)