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

NCT01889771 | Completed

• 1 other identifier: 09-0757
• Study Type: interventional
• Target: 1,495
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• 7-day smoking abstinence

  7 days

• 6-month smoking abstinence

  6 months

• 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

Study Arms (2)

Nicotine Patch (4 weeks)

EXPERIMENTAL

participants receive one 4-weeks supply of nicotine patches

Drug: Nicotine Patch

Nicotine Patch (8 weeks)

EXPERIMENTAL

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

Drug: Nicotine Patch

Interventions

Nicotine Patch DRUG

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

Also known as: Nicoderm Committed Quit patches

Nicotine Patch (4 weeks); Nicotine Patch (8 weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Related Publications (2)

• 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.

  PMID: 37335995 DERIVED

• 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.

  PMID: 25416755 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Emily K Burns

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 28, 2013
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 11, 2016

Record last verified: 2016-02