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

Status

Completed

Conditions

Intervention / Treatment

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
Drug: Nicotine Patch
nicoderm patches are distributed in two different supplies through a telephone quitline
Other Names:
  • Nicoderm Committed Quit patches
Experimental: Nicotine Patch (8 weeks)
participants receive up to 8 weeks of nicotine patches in up to two 4-week supplies
Drug: Nicotine Patch
nicoderm patches are distributed in two different supplies through a telephone quitline
Other Names:
  • Nicoderm Committed Quit patches

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

University of Colorado, Denver

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.

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

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.

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