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Active, not recruiting

NCT Number: NCT06862050

BREATHE Free Curriculum

The purpose of this study is to evaluate whether BREATHE Free, an in-person faith-based smoking cessation program, can help people quit using tobacco products, including cigarettes, cigars, cigarillos, and e-cigarettes/vapes.

The program consists of 12 weekly group sessions that teach character strengths and resilience-based skills, such as hope, love, and spirituality, using the BREATHE Free curriculum. Participants will also receive free nicotine patches and complete surveys about their tobacco use, character strengths, and resilience.

The study will help us improve the program and determine whether it can reduce or eliminate tobacco use. Success will be measured through participant surveys and verified using expired carbon monoxide (CO) testing, a standard method for confirming smoking cessation.

The main question is: Can participation in the BREATHE Free program help people reduce or quit tobacco use?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Smoking Cessation; Tobacco Dependence Behavior Chemically-Induced Disorders E-Cig Use Health Behavior Mental Disorders Nicotine Dependence, Other Tobacco Product Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current use of one or more tobacco products
  • Valid home address in Augusta or the CSRA and able to attend sessions in person held in Augusta, Ga
  • Functioning telephone number
  • Speak, read, write in English

Treatment and study plan

BREATHE Free Curriculum

Behavioral

The curriculum teaches 12 character strengths and resilience practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamwork, perseverance, gratitude, and joy. Each weekly session includes music and movement activities, instruction and discussion focused on one practice, goal setting, and meditation exercises including deep breathing, mindfulness, prayer, gratitude, and forgiveness.

Primary outcomes

  1. Number of participants who stopped smoking completely

    Time frame: Measured at week 12

    Biochemically verified point prevalence abstinence (7 days)

  2. Number of participants who achieved a ≥50% reduction in tobacco use from baseline

    Time frame: Measured in baseline and weeks 12

    Number of participants who achieved a ≥50% reduction in tobacco use from baseline, defined as a reduction of at least 50% in the number of cigarettes smoked per day or the number of vaping episodes per day, measured at Week 12 compared with baseline.

Secondary outcomes

  1. Number of participants who rated the intervention positively at week 12

    Time frame: Program evaluation will be administered on last meeting (week 12)

    Number of participants who rated the BREATHE Free intervention favorably (scores of 4 or 5) on the following acceptability and perceived effectiveness items.

    Participants will rate their agreement with each statement using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree):

    BREATHE Free gave me confidence that I can quit tobacco use. BREATHE Free made me think that quitting tobacco is worthwhile. BREATHE Free made me feel that someone cared whether I quit smoking. BREATHE Free helped me understand the right steps to quit smoking.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2025
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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