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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine Patch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
Study Start Date : March 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Nicoderm Committed Quit patches




Primary Outcome Measures :
  1. 7-day smoking abstinence [ Time Frame: 7 days ]
  2. 6-month smoking abstinence [ Time Frame: 6 months ]
  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889771


Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Emily K Burns University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01889771    
Other Study ID Numbers: 09-0757
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action