BREATHE Free: a Pilot Feasibility Trial (BF)

Augusta University

Status: Enrolling

Conditions: Nicotine Dependence, Other Tobacco Product; E-Cig Use; Smoking Cessation; Tobacco Dependence

Treatments: Behavioral: BREATHE Free Curriculum

Study type: Interventional

Funder types: Other

Identifiers

NCT06862050

2051137

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 criteria

• Current use of tobacco cessation medications
• Enrolled in tobacco treatment program

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

BREATHE Free

Experimental group

Description:

Attend 12 in-person weekly meetings and go through Breathe Free curriculum.

Treatment:

Behavioral: BREATHE Free Curriculum

Control

No Intervention group

Description:

This group will serve as a control group and will receive usual care, referral to tobacco quit line.