Financial incentives in Tobacco Use Disorder - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Tobacco Use Disorder

Intervention / Treatment

Behavioral: Financial incentives

Detailed Description

Smoking is the leading cause of preventable mortality in United States, accounting for approximately 435,000 of the 2.4 million deaths each year in the United States. Most smokers make multiple attempts to quit smoking, but only 2-3% succeed each year. Smoking cessation programs have proven effective in helping smokers quit, but only about 5% of smokers enroll in smoking cessation programs each year.

Financial incentives have been shown to increase enrollment in smoking cessation programs and short-term quit rates, but have not been well tested as a mechanism for increasing long-term quit rates. The existing evidence suggests that they could be highly effective, particularly among heavy smokers and low income smokers. In addition, financial incentives for smoking cessation will likely be more cost effective than most covered health services and at least as cost effective as other recommended smoking cessation treatments.

This study is a two-arm randomized clinical trial of financial incentives for smoking cessation among a sample of 850 male and female smokers from GE Energy worksites throughout the U.S. Smokers will be randomized to receive either usual care (information about local community-based smoking cessation resources, coverage of prescription drugs and physician visits) or usual care plus a package of financial incentives that includes $100 for completion of a community-based tobacco cessation program, $250 for short-term smoking cessation at either 3 months or 6 months after randomization, and $400 for smoking cessation 6 months post-quit date (biochemically confirmed).

Study Type

Interventional

Enrollment

878

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
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-6021
    - University of Pennsylvania School of Medicine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Employees of General Electric at work sites in the United States
Current smokers who report having smoked at least 5 cigarettes per day for the prior 12 months
Age 18 or older

Exclusion Criteria:

Current use of other tobacco products, such as chewing tobacco, pipes, or cigars
Planning to leave General Electric within the next 18 months

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: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Biochemically verified smoking cessation rates at 6 months post-quit date

Secondary Outcome Measures

Outcome Measure
Enrollment in and completion of community-based smoking cessation programs within the first 6 months after randomization
Short-term quit rates at 3 months or 6 months post-quit date
Quit rates at 12 months post-quit date

Collaborators and Investigators

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

Sponsor

University of Pennsylvania

Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator: Kevin G Volpp, MD, PhD, University of Pennsylvania

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

Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.

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

March 1, 2005

Study Completion

April 1, 2008

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria