A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

Smoking Cessation Clinical Trial

Official title:

A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889771
• Other study ID #: 09-0757
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: February 9, 2016
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: February 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1495
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine Patch
nicoderm patches are distributed in two different supplies through a telephone quitline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day smoking abstinence		7 days	No
Primary	6-month smoking abstinence		6 months	No
Primary	cost-effectiveness	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	No