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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Smoking Cessation

Treatments: Drug: Nicotine Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT01889771

09-0757

Details and patient eligibility

About

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.

Enrollment: 1,495 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,495 participants in 2 patient groups

Nicotine Patch (4 weeks)

Experimental group

Description:

participants receive one 4-weeks supply of nicotine patches

Treatment:

Drug: Nicotine Patch

Nicotine Patch (8 weeks)

Experimental group

Description:

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

Treatment:

Drug: Nicotine Patch