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An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01047527
First received: January 11, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Condition Intervention Phase
Nicotine Dependence
Drug: Transdermal nicotine patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • point prevalence abstinence [ Time Frame: 52-week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • smoking rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 525
Study Start Date: June 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 8 weeks transdermal nicotine
8 weeks of transdermal nicotine
Drug: Transdermal nicotine patch
Transdermal nicotine, 21mg/day
Active Comparator: 24 weeks transdermal nicotine
24 weeks of transdermal nicotine
Drug: Transdermal nicotine patch
Transdermal nicotine, 21mg/day
Experimental: 52 weeks transdermal nicotine
52 weeks of transdermal nicotine
Drug: Transdermal nicotine patch
Transdermal nicotine, 21mg/day

Detailed Description:

The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe. Yet, abstinence rates following patch treatment are only ~20% at 6-months and ~9% at 12-months. There is a growing recognition that nicotine dependence is a chronic disease, like asthma or diabetes, which requires maintenance therapy. While current guidelines established by the USDHHS's Public Health Service (PHS) recommend 8-week duration for transdermal nicotine therapy, support for this recommendation is limited. In a recent randomized placebo-controlled efficacy trial comparing standard (8-week) vs. extended (24-weeks) treatment with nicotine patches, we found that, at 24 weeks, point-prevalence abstinence rates were 30% in the 24-week arm vs. 20% in the standard therapy arm (p < .05); however, by week 52, 6 months after treatment was discontinued for the extended treatment arm, the quit rates were equivalent across the treatment arms. This was the first clinical trial to suggest that the benefits of extended treatment with transdermal nicotine are largely dependent on the continuation of active treatment. However, as an efficacy trial, this study was conducted under highly-controlled conditions with strict inclusion/exclusion criteria to enhance internal validity. If recommendations for the duration of nicotine patch therapy are to be formally revised to encourage maintenance therapy, these findings must be replicated and extended under "real-world circumstances" in an effectiveness trial. In addition, as done in clinical trials to support the use of methadone maintenance for opiate dependence, a replication study must include a treatment arm that receives maintenance therapy throughout the duration of the trial (52 weeks). Thus, we propose to conduct a randomized effectiveness trial to evaluate the benefits of maintenance therapy with transdermal nicotine patches for smoking cessation. Specifically, 540 smokers will receive brief counseling and will be randomized to: standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) transdermal nicotine therapy. The primary outcome will be biochemically verified 7-day point prevalence abstinence at week 52. Additional study aims include assessing: 1) treatment side effects across study arms; 2) longitudinal patterns of relapse and recovery across treatment arms; 3) mediators and moderators of treatment effects; and 4) cost-effectiveness. Overall, the trial findings will provide critical data for future PHS reviews of maintenance therapy with transdermal nicotine for subsequent treatment guidelines; for third-party payer assessments of maintenance transdermal nicotine as a covered benefit; and for individual smokers' decisions to use maintenance transdermal nicotine through over-the-counter access. In turn, this study may help to attain the Healthy People 2010 goals of reducing the US rate of tobacco use.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Participants will be: 1) males and females over age 18 who smoke at least 10 cigarettes/day; 2) able to communicate in English; 3) able to use NRT safely (e.g., no allergy to latex, no serious abnormal ECG reading); 4) able to provide written informed consent for study procedures; and 5) residing in the geographic area for at least 12 months.

Exclusion Criteria: Participants will be ineligible for the trial if they: 1) are unable to communicate in English; 2) Have a current diagnosis of psychosis and/or manic depression; 3) have a current medical condition that would make using transdermal nicotine patch unsafe (e.g., allergy to latex, serious, abnormal ECG reading)- participants with asthma, diabetes, hypertension, or heart disease (e.g., coronary artery disease, abnormal heart rhythm, an arrhythmia) will be permitted to enroll in the study with medical clearance from the participant's physician or the study physician; 4) have had a heart attack within the past 6 months, 5) are pregnant or planning to become pregnant or lactating, or 6) are currently enrolled or plan to enroll in another research or smoking cessation program within the next 12 months.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047527

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Brian Hitsman, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Robert Schnoll, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01047527     History of Changes
Other Study ID Numbers: DESPR DA025078, R01DA025078-02
Study First Received: January 11, 2010
Last Updated: August 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
nicotine replacement therapy, smoking cessation, transdermal nicotine

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014