BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

Summary

The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when compared against a standard outreach approach. Only patients at participating adult primary care clinics will be eligible for the study. Five clinic sites will be randomized to an enhanced outreach approach, while another 5 will be randomly assigned to standard smoking treatment outreach. Eligible patients at these clinics will be in this study for up to 18 months.

Conditions

• Quitting Smoking
• Smoking Cessation
• Smoking, Cigarette

Interventions

BEHAVIORAL

Text message smoking treatment

Facilitated enrollment in an NCI-sponsored text messaging program: * SmokefreeTXT (if ready to set a quit date in the next 14 days) * Practice Quit (if ready to practice quitting 1-5 days but not ready to quit permanently) * Daily Challenges (if not ready to quit, but willing to make some changes)

DRUG

Nicotine replacement therapy sampling

Participants may request: * Nicotine patches that release nicotine slowly over 24 hours, in either 7 mg, 14 mg, or 21 mg doses * Nicotine gum or lozenges that release medication quickly and can be used every 1-2 hours to prevent and cope with cravings to smoke, in either 2 mg or 4 mg doses

COMBINATION_PRODUCT

Wisconsin Tobacco QuitLine Referral

Patients will be offered referral to the Wisconsin Tobacco QuitLine that offers phone counseling and nicotine replacement starter kits (2 week supplies) to people ready to quit smoking, in addition to web-based, text messaging, and mailed support, at no cost to Wisconsin residents.

COMBINATION_PRODUCT

Referral to Primary Care Provider

Patients who want to talk to their Primary Care Providers about quitting smoking will be encouraged to make an appointment with their provider to receive smoking cessation counseling and to discuss pharmacotherapy options.

COMBINATION_PRODUCT

BREATHE 2 Cessation Study

Patients who are interested in participating in a separate randomized controlled trial of smoking cessation treatment will be invited to learn about and complete an eligibility screening and consent process for the trial. Those who enter the study receive both counseling and pharmacotherapy.

BEHAVIORAL

Additional modalities to learn about and request treatment

Participants in Enhanced Outreach arm clinics will have the option to request e-mail and/or text message communication regarding their smoking treatment options, and to initiate treatment via phone or online survey.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Danielle E McCarthy, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-24

Primary Completion

2025-05-07

Completion

2025-05-07

Countries

• United States

Study Locations