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BREATHE Free Curriculum

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 25, 2026 → Dec 25, 2027
Primary endpoint removed 3 → 2 primary endpoints
Enrollment reduced 72% 90 → 25 participants
See other at-risk trials from Augusta University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 25, 2026 to Dec 25, 2027 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 90 → 25 participants
    • Enrollment closed, study ongoing
    • Trial arms changed: 2 → 1
    • Secondary endpoints: 3 to 1
    • Site details revised
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT06862050
Lead Sponsor Augusta University
Conditions
(from sponsor)		 Smoking Cessation; Tobacco Dependence, E-Cig Use, Nicotine Dependence, Other Tobacco Product
Related terms Smoking Cessation, Tobacco Use Disorder, Vaping
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov