BREATHE Free: a Pilot Feasibility Trial

Last updated: March 3, 2025
Sponsor: Augusta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tobacco Use Disorder

Treatment

BREATHE Free Curriculum

Clinical Study ID

NCT06862050
2051137
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL).

The intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit.

The main questions it aims to answer are:

  • Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use?

  • Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day?

Researchers will assign participants to either BREATHE Free curriculum or usual care.

Participants will:

  • Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line

  • BREATHE Free group will attend 12 group meetings held on the university campus

  • All participants will answer interview questions related to tobacco use, character strengths and resilience

  • Expired Carbon Monoxide (CO) will be assessed in all participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Daily use of one or more tobacco products

  • Valid home address in Augusta or the CSRA

  • Functioning telephone number

  • Speak, read, write in English

Exclusion

Exclusion Criteria:

  • Current use of tobacco cessation medications

  • Enrolled in tobacco treatment program

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: BREATHE Free Curriculum
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
December 25, 2026

Connect with a study center

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

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