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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00128375
Other study ID # 802295
Secondary ID 1-R01-DP-000100-
Status Completed
Phase N/A
First received August 8, 2005
Last updated December 12, 2007
Start date March 2005
Est. completion date April 2008

Study information

Verified date December 2007
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of financial incentives for increasing long-term smoking cessation rates among employees at General Electric worksites throughout the United States.


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).


Recruitment information / eligibility

Status Completed
Enrollment 878
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial incentives


Locations

Country Name City State
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biochemically verified smoking cessation rates at 6 months post-quit date
Secondary Enrollment in and completion of community-based smoking cessation programs within the first 6 months after randomization
Secondary Short-term quit rates at 3 months or 6 months post-quit date
Secondary Quit rates at 12 months post-quit date
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