CClinicalTrials.gg
CompletedNCT01889771Updated Feb 11, 2016

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

An interventional study of Nicotine Patch in Smoking Cessation, sponsored by University of Colorado, Denver. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-11.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,495
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking Cessation
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,495 participants (actual)

Study arms

  • Experimental
    Nicotine Patch (4 weeks)

    participants receive one 4-weeks supply of nicotine patches

    Drug: Nicotine Patch

  • Experimental
    Nicotine Patch (8 weeks)

    participants receive up to 8 weeks of nicotine patches in up to two 4-week supplies

    Drug: Nicotine Patch

Interventions

  • DrugNicotine Patch

    nicoderm patches are distributed in two different supplies through a telephone quitline

    Also known as: Nicoderm Committed Quit patches

06

What researchers measure

Primary outcomes

  1. 7-day smoking abstinence

    Time frame: 7 days

  2. 6-month smoking abstinence

    Time frame: 6 months

  3. 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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Burns EK, Hood NE, Goforth E, Levinson AH. Randomised trial of two nicotine patch protocols distributed through a state quitline. Tob Control. 2016 Mar;25(2):218-23. doi: 10.1136/tobaccocontrol-2014-051843. Epub 2014 Nov 21. PubMed 25416755 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01889771
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jun 28, 2013
Start date
Mar 2010
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Feb 11, 2016

Study contacts

Emily K Burns
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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