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

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ClinicalTrials.gov Identifier: NCT01889771
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date February 11, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • 7-day smoking abstinence [ Time Frame: 7 days ]
  • 6-month smoking abstinence [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • 7-day smoking abstinence [ Time Frame: 6 months ]
  • 6-month smoking abstinence [ Time Frame: 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
Official Title  ICMJE A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Drug: Nicotine Patch
nicoderm patches are distributed in two different supplies through a telephone quitline
Other Name: Nicoderm Committed Quit patches
Study Arms  ICMJE
  • Experimental: Nicotine Patch (4 weeks)
    participants receive one 4-weeks supply of nicotine patches
    Intervention: Drug: Nicotine Patch
  • Experimental: Nicotine Patch (8 weeks)
    participants receive up to 8 weeks of nicotine patches in up to two 4-week supplies
    Intervention: Drug: Nicotine Patch
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2013)
1495
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889771
Other Study ID Numbers  ICMJE 09-0757
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily K Burns University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP