Smoking Cessation; Tobacco DependenceNCT06862050
BREATHE Free Curriculum
A study testing BREATHE Free Curriculum in people with Smoking Cessation; Tobacco Dependence and E-Cig Use, run by Augusta University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation; Tobacco Dependence, E-Cig Use, Nicotine Dependence, Other Tobacco Product
- What is being tested?
- BREATHE Free Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 25 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment
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.
Read more
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?
- Conditions
- Smoking Cessation; Tobacco Dependence, E-Cig Use, Nicotine Dependence, Other Tobacco Product
- Being tested
- BREATHE Free Curriculum
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHE Free CurriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BREATHE Free | Experimental | Attend 12 in-person weekly meetings and go through Breathe Free curriculum. Receives: Behavioral: BREATHE Free Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who stopped smoking completely
Biochemically verified point prevalence abstinence (7 days)
Measured: Measured at week 12
Number of participants who achieved a ≥50% reduction in tobacco use from baseline
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.
Measured: Measured in baseline and weeks 12
Secondary outcomes (1)
Number of participants who rated the intervention positively at 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.
Measured: Program evaluation will be administered on last meeting (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Mar 2025
- Primary completion25 Dec 2027 (estimated)
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking Cessation; Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ban Majeed, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862050
- Sponsor's protocol ID
- 2051137
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment
- ClinicalTrials.gov ID
- NCT06862050
- Acronym / sponsor ID
- 2051137
- Conditions
- Smoking Cessation; Tobacco Dependence, E-Cig Use, Nicotine Dependence, Other Tobacco Product
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BREATHE Free | Experimental | Behavioral: BREATHE Free CurriculumAttend 12 in-person weekly meetings and go through Breathe Free curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREATHE Free CurriculumThe 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. | Behavioural | BREATHE Free |
Primary outcome
Number of participants who stopped smoking completely
Time frame: Measured at week 12
Biochemically verified point prevalence abstinence (7 days)
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.
1 secondary outcome
Number of participants who rated the intervention positively at week 12
Time frame: Program evaluation will be administered on last meeting (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHE Free Curriculum in people with Smoking Cessation; Tobacco Dependence and E-Cig Use, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who stopped smoking completely (time frame: Measured at week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.