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

NCT ID: NCT01889771

Last Updated: 2016-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Nicotine Patch (4 weeks)

participants receive one 4-weeks supply of nicotine patches

Group Type EXPERIMENTAL

Nicotine Patch

Intervention Type DRUG

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

Nicotine Patch (8 weeks)

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

Group Type EXPERIMENTAL

Nicotine Patch

Intervention Type DRUG

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

Interventions

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Nicotine Patch

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

Intervention Type DRUG

Other Intervention Names

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Nicoderm Committed Quit patches

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily K Burns

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

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Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

Reference Type DERIVED
PMID: 37335995 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25416755 (View on PubMed)

Other Identifiers

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09-0757

Identifier Type: -

Identifier Source: org_study_id

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