Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation - Full Text View

Sponsored by:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00364156

Purpose

We propose to conduct a randomized, double-blind, placebo-controlled trial to determine the effects of extended versus standard TN treatment among smokers genotyped for the OPRM1 Asn40Asp variant (see figure below). Specifically, after undergoing an eligibility screening and study orientation process, 900 eligible, consenting 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). Participants will be randomized to either ST or ET, stratified by OPRM1 genotype such that there will be equal numbers of participants with the Asn40 randomized to each treatment arm, and similarly, equal numbers of people with the Asp40 variant in each treatment arm. All participants will receive behavioral counseling. We hypothesize that participants receiving ET will have higher quit rates than those receiving ST. Further, we expect to see an interaction between treatment duration and genotype such that in smokers who carry at least one copy of the OPRM1 Asp40 variant (Asn/Asp, Asp/Asp), ET (compared to ST) will lead to significantly higher abstinence rates.

Condition	Intervention	Phase
Tobacco Use Cessation	Drug: 8-weeks of nicotine patch + 16-weeks of placebo Drug: 24-weeks of nicotine patch	Phase IV

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Biochemically verified 7-day point prevalence at end of treatment.

Secondary Outcome Measures:

Prolonged abstinence with relapse defined as seven consecutive days of smoking.

Estimated Enrollment:	900
Study Start Date:	June 2004

Eligibility

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

Criteria

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).

Contacts and Locations

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

Contacts

Contact: Freda Patterson, Ph.D.

fredap@mail.med.upenn.edu

Locations

United States, Pennsylvania
Tobacco Use Research Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Caryn Lerman, Ph.D.

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

Caryn Lerman, Ph.D.

University of Pennsylvania

More Information

Study ID Numbers:	801851
Study First Received:	August 14, 2006
Last Updated:	January 11, 2007
ClinicalTrials.gov Identifier:	NCT00364156
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009