Transdermal nicotine patches and Motivational interview in Tobacco Use - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Tobacco Use

Intervention / Treatment

Detailed Description

In urban communities, the prevalence of tobacco use among adults visiting a hospital emergency department (ED) nears 40%, well in excess of the 25% smoking prevalence rate of the general population. Many of these patients lack easy access to primary care, suggesting the ED may be an attractive locus to initiate tobacco cessation efforts. With over 100 million annual visits to U.S. EDs, it may be possible to engage millions of smokers in tobacco cessation efforts. The major purpose of this study is to examine whether a multicomponent intervention delivered in the ED by a Lay Educator to adult smokers interested in quitting is more likely to result in cessation than usual care. A secondary goal is to test whether patients who present to the ED with a tobacco-related illness (as indicated by ICD9 code) are more likely to quit than ED smokers with a non-tobacco-related condition. This will allow us to test the validity of the "teachable moment" as an opportune time to engage patients in considering a behavioral change. The proposed study is a randomized trial of a motivational interview, provision of six weeks' worth of nicotine patches, literature, and post-visit follow-up (Enhanced Care) vs. referral to a cessation clinic (Minimal Care) for ED patients who smoke. Eligibility criteria: age > 21 years, contemplation or preparation stage of change, not admitted to hospital. All patients will undergo a standardized stage of change assessment, and measurements of nicotine dependence and exhaled carbon monoxide. All will receive a cessation fact sheet and referral card to the smoking cessation clinic; the cards of those in the Enhanced Care group will have a specific appointment date and time. The Enhanced Care group will receive a language-appropriate pamphlet discussing smoking cessation. We will record the ICD9 codes associated with each visit. Major outcome measure: cessation within 3 months of the ED visit, stratified by treatment group. Secondary outcome measure: cessation within 3 months of the ED visit, stratified by whether the visit was smoking-related. If smokers receiving Enhanced Care are more likely to quit, then the ED could be considered a new, effective locus for tobacco control, potentially reaching several million smokers. If patients with a smoking-related diagnosis for the ED visit are more likely to quit than those with non-smoking-related ICD9, then this supports the construct of the teachable moment.

Study Type

Interventional

Enrollment (Anticipated)

336

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

>= 10 cigarettes smoked daily
being discharged from the ED
contemplation or preparation stage of change
speaks English or Spanish

Exclusion Criteria:

being admitted to hospital
too ill to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
3-month cessation rate

Secondary Outcome Measures

Outcome Measure
3-month quit attempts,
daily cigarette consumption,
stage of change assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Steven L. Bernstein, MD, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria