A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
February 9, 2016 updated by: University of Colorado, Denver
The study is to understand whether distribution of two different supplies of nicotine patches through a telephone quitline has an effect on quit rates.
The two different supplies are four vs. eight (in two separate four-week mailings) weeks of nicotine patches.
The hypothesis is that eight weeks will be slightly more efficacious but four weeks will be more cost-effective.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1495
Phase
- Not Applicable
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:
- All callers to the Colorado QuitLine who report currently smoking 16-20 cigarettes
- who enroll in QuitLine services
- who do not require physician approval to obtain nicotine replacement therapy
- who are willing to receive the nicotine patch
Exclusion Criteria:
- Contraindications to receiving the nicotine patch through the QuitLine without physician approval include: history of hearth disease (heart attack, chest pain, or coronary artery disease), high blood pressure, pregnancy, skin conditions such as difficult to manage psoriasis or eczema, or history of a local reaction to the nicotine patch
- those who do not complete the call in English
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nicotine Patch (4 weeks)
participants receive one 4-weeks supply of nicotine patches
|
nicoderm patches are distributed in two different supplies through a telephone quitline
Other Names:
|
|
Experimental: Nicotine Patch (8 weeks)
participants receive up to 8 weeks of nicotine patches in up to two 4-week supplies
|
nicoderm patches are distributed in two different supplies through a telephone quitline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
7-day smoking abstinence
Time Frame: 7 days
|
7 days
|
|
|
6-month smoking abstinence
Time Frame: 6 months
|
6 months
|
|
|
cost-effectiveness
Time Frame: 6 months
|
cost per quit of each study arm will be calculated based on the total costs of the intervention from actual utilization data (nicotine patch costs + counseling call costs) and quit rates
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emily K Burns, University of Colorado, Denver
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.
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, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
June 14, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Estimate)
February 11, 2016
Last Update Submitted That Met QC Criteria
February 9, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-0757
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.