NCT00364156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 2, 2010

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

3.8 years

First QC Date

August 14, 2006

Results QC Date

October 6, 2010

Last Update Submit

February 26, 2018

Conditions

TOBACCO USE CESSATION

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Extended Patch Treatment

EXPERIMENTAL

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

Standard Patch Treatment

ACTIVE COMPARATOR

Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.

Drug: Standard Patch Treatment

Interventions

Standard Patch TreatmentDRUG

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

Standard Patch Treatment
24-weeks of nicotine patchDRUG

24-weeks of 21mg nicotine patch

Extended Patch Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tobacco Use Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

  • 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.

    PMID: 18328642RESULT

  • 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.

    PMID: 20124230RESULT

  • 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.2008.10.016. Epub 2008 Oct 31.

    PMID: 19000709RESULT

  • 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: 10.1038/clpt.2010.3. Epub 2010 Mar 24.

    PMID: 20336063RESULT

  • 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 dependence. Neuropsychopharmacology. 2010 May;35(6):1374-82. doi: 10.1038/npp.2010.7. Epub 2010 Feb 10.

    PMID: 20147892RESULT

  • Ashare RL, Wileyto EP, Perkins KA, Schnoll RA. The first 7 days of a quit attempt predicts relapse: validation of a measure for screening medications for nicotine dependence. J Addict Med. 2013 Jul-Aug;7(4):249-54. doi: 10.1097/ADM.0b013e31829363e1.

    PMID: 23669629DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Dr. Caryn Lerman
Organization
University of Pennsylvania
clerman@mail.med.upenn.edu
215-746-7141

Study Officials

  • Caryn Lerman, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

June 1, 2004

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

February 28, 2018

Results First Posted

November 2, 2010

Record last verified: 2018-02

Locations

US(2)