Recruiting

Observational Study

Sponsor:

Augusta University

Code:

NCT06862050

Conditions

Smoking Cessation; Tobacco Dependence

E-Cig Use

Nicotine Dependence, Other Tobacco Product

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

BREATHE Free Curriculum

Study Details

Brief 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.

Conditions

Smoking Cessation; Tobacco Dependence

E-Cig Use

Nicotine Dependence, Other Tobacco Product

Study ID

NCT06862050

Start date

Mar 1, 2025

Status verified date

Mar, 2025

Completion date

Dec 25, 2026

Anticipated

Primary completion date

Dec 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BREATHE Free

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

no intervention: Control

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

Interventions

BREATHE Free Curriculum

Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.

Primary outcome measure

  • Engagement [ Time Frame: Weekly assessments, with first assessment in week 2 and last assessment in week 12. ]
  • Acceptability [ Time Frame: Program evaluation will be administered on last meeting (week 12). ]
  • Acceptability [ Time Frame: Program evaluation will be administered on last meeting (week 12). ]

Central Contacts and Locations

Central contacts

Ban A Majeed, PhD

7067210806bmajeed@augusta.edu

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Ban A Majeed, PhD

706-721-0806bmajeed@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Mar 6, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2025-03-06.