Smoking CessationANBL-INCT04931810
Urban and Reservation Implementation of All Nations Breath of Life
A study testing All Nations Breath of Life in people with Smoking Cessation, run by Lehigh University at 1 site in United States.
Trial summary
This is an implementation trial of the All Nations Breath of Life (ANBL) smoking cessation program, which has already been tested for efficacy in reservation populations and shown feasibility in urban populations. It includes four implementation sites, two reservation sites and two urban sites. 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
- What is being tested?
- All Nations Breath of Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 26 Jan 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
- Self-identified American Indian or allowed to enroll by community site
- Age 18 or older
- Smokes at least one cigarette per day
- Planning to quit smoking
- Have a home address and telephone number
- Willing to be followed for 6 months
- Willing to participate
Who cannot join
- Any of the above do not apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urban an Reservation Implementation of All Nations Breath of Life to Improve Smoking Cessation Rates Among American Indians
This is an implementation trial of the All Nations Breath of Life (ANBL) smoking cessation program, which has already been tested for efficacy in reservation populations and shown feasibility in urban populations. It includes four implementation sites, two reservation sites and two urban sites. Therefore, investigators plan to test efficacy simultaneously. Implementation will follow guidelines described in the protocol, with all sites implementing certain parts of the intervention the same way, with the freedom to modify some aspects of the intervention for appropriate use in their communities. Statistical considerations are described in the appropriate section.
Read the detailed description
All Nations Breath of Life (ANBL) is a culturally tailored, group-based quit smoking program for American Indian (AI) people. For this project, there are certain aspects of ANBL that are maintained across all sites. There are other aspects that may be modified at different sites to best fit the community. The aspects of the program that are maintained include:
Group Support Sessions: The primary component of ANBL is group-based support sessions, led by an AI community member. Due to low rates of educational attainment among AI, the study team decided to not limit session leaders to individuals with counseling degrees; investigators will train community members in group support and counseling skills. Group leaders are not called "counselors" due to community reticence to trust providers trained in Western counseling. Investigators chose the term "facilitator" because this role facilitates discussion and creates positive interactions. All group sessions begin with team building and discussion about things people are experiencing in their lives, both those related directly to smoking and other things that help or hinder quit attempts. The first group session is devoted to forming a cohesive group and learning about individual journeys with tobacco. Participants are asked to bring their primary support person with them. This is the quit date for all participants to ensure they go through the process together. During the traditional tobacco session, participants bring personal items about traditional tobacco and can conduct a group ceremony signifying the end of their journey with recreational tobacco and celebrating it as a sacred plant. Facilitators acknowledge the diversity of tobacco use (or nonuse) and adjust the session as appropriate. There are two "Family Sessions" (weeks 7 and 12) where participants bring family or household members to a group dinner to mobilize support and reinforce family-level intervention components. Guests are provided with additional information about how to support someone who is trying to quit. One support person is asked to attend additional sessions with the person they are supporting; this person is welcome at any and all sessions. All attendees are taught the importance of home smoking rules and are encouraged to implement them, along with the individual trying to quit. The study team will track social support and home smoking rules throughout the program to identify any impact they may have on quitting through surveys with the individual who is quitting, asking them to identify how they are being supported and what types of home smoking rules have been implemented. Support people will not be considered study participants and will not complete surveys. This is done at the request of community members because they believe it will be more difficult to get support people to participate if they must also be subjects of research.
Individual Telephone Counseling: Between groups, facilitators call participants to see how they are doing and if they are having side effects to medications, discuss personal issues, and to remind them of the next group. Facilitators use Motivational Interviewing (MI) counseling techniques. MI has shown effectiveness with AI, is designed to enhance motivation and is based on the assumption that many people with addictions are not in an advanced state of readiness to change. The goal is to increase motivation by developing a discrepancy between behavior and goals. The study team developed culturally sensitive MI scripts to conduct telephone sessions exploring positive and negative aspects of, ambivalence about and motivation/confidence for quitting, the pros and cons of behavior change, and plans for change. Because previous ANBL participants and facilitators have not believed that MI has been instrumental in participant ability to quit and because some have found it to be burdensome, investigators leave it up to individual sites whether they will use MI or not, tracking use for secondary analyses.
Educational Curriculum: The curriculum includes 11 brochures, given throughout the program; it combines cessation information with cultural elements. Community members have stressed throughout development that cultural issues must be ingrained in the program and its accompanying materials, not given "lip service" by putting AI pictures on "White" materials. These materials were created by the study team and Community Advisory Board (CAB) members, with input from pilot participants, then sent to an AI graphic artist for final layout.
Pharmacotherapy: Current treatment guidelines suggest pharmacotherapy be offered to all smokers making a quit attempt. Study sites may work in conjunction with health centers and pharmacies to provide medication if they so choose; it is not provided as a part of the study. Participants must be under the care of a physician to receive prescription medication. Sites are required to track participant use of medication.
- Conditions
- Smoking Cessation
- Being tested
- All Nations Breath of Life
- Keywords
- American Indian, smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All Nations Breath of LifeBehavioural
Same.
| Study group | Role | What they receive |
|---|---|---|
| All Nations Breath of Life | Experimental | ANBL is a culturally tailored smoking cessation program that incorporates group-based and individual counseling. Participants may elect to take pharmacotherapy, but are not required to do so. Receives: Behavioral: All Nations Breath of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Cessation measured by self-report and expired Carbon Monoxide (CO)
Measured: 7-day point prevalence abstinence at 6 months
Secondary outcomes (1)
Smoking Cessation 2
Cessation measured by self-report and expired CO
Measured: 30-day point prevalence and continuous abstinence at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Apr 2021
- Primary completion27 Jan 2026
- Study completion26 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Model description
- All community sites will implement the program as most appropriate for their communities.
- Masking
- None (open label)
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lehigh University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christine M Daley, PhD, Principal investigator, Lehigh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931810
- Sponsor's protocol ID
- 1595875-2
- Other IDs
- R01DA047863
- Acronym
- ANBL-I
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urban an Reservation Implementation of All Nations Breath of Life to Improve Smoking Cessation Rates Among American Indians
- ClinicalTrials.gov ID
- NCT04931810
- Acronym / sponsor ID
- ANBL-I / 1595875-2
- Conditions
- Smoking Cessation
- Keywords
- American Indian, smoking cessation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Lehigh UniversityUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center, National Institute on Drug Abuse (NIDA)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 26 Jan 2027 (estimated)
- First posted
- 18 Jun 2021 (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.
This is an implementation trial of the All Nations Breath of Life (ANBL) smoking cessation program, which has already been tested for efficacy in reservation populations and shown feasibility in urban populations. It includes four implementation sites, two reservation sites and two urban sites. Therefore, investigators plan to test efficacy simultaneously. Implementation will follow guidelines described in the protocol, with all sites implementing certain parts of the intervention the same way, with the freedom to modify some aspects of the intervention for appropriate use in their communities. Statistical considerations are described in the appropriate section.
Detailed description
All Nations Breath of Life (ANBL) is a culturally tailored, group-based quit smoking program for American Indian (AI) people. For this project, there are certain aspects of ANBL that are maintained across all sites. There are other aspects that may be modified at different sites to best fit the community. The aspects of the program that are maintained include:
Group Support Sessions: The primary component of ANBL is group-based support sessions, led by an AI community member. Due to low rates of educational attainment among AI, the study team decided to not limit session leaders to individuals with counseling degrees; investigators will train community members in group support and counseling skills. Group leaders are not called "counselors" due to community reticence to trust providers trained in Western counseling. Investigators chose the term "facilitator" because this role facilitates discussion and creates positive interactions. All group sessions begin with team building and discussion about things people are experiencing in their lives, both those related directly to smoking and other things that help or hinder quit attempts. The first group session is devoted to forming a cohesive group and learning about individual journeys with tobacco. Participants are asked to bring their primary support person with them. This is the quit date for all participants to ensure they go through the process together. During the traditional tobacco session, participants bring personal items about traditional tobacco and can conduct a group ceremony signifying the end of their journey with recreational tobacco and celebrating it as a sacred plant. Facilitators acknowledge the diversity of tobacco use (or nonuse) and adjust the session as appropriate. There are two "Family Sessions" (weeks 7 and 12) where participants bring family or household members to a group dinner to mobilize support and reinforce family-level intervention components. Guests are provided with additional information about how to support someone who is trying to quit. One support person is asked to attend additional sessions with the person they are supporting; this person is welcome at any and all sessions. All attendees are taught the importance of home smoking rules and are encouraged to implement them, along with the individual trying to quit. The study team will track social support and home smoking rules throughout the program to identify any impact they may have on quitting through surveys with the individual who is quitting, asking them to identify how they are being supported and what types of home smoking rules have been implemented. Support people will not be considered study participants and will not complete surveys. This is done at the request of community members because they believe it will be more difficult to get support people to participate if they must also be subjects of research.
Individual Telephone Counseling: Between groups, facilitators call participants to see how they are doing and if they are having side effects to medications, discuss personal issues, and to remind them of the next group. Facilitators use Motivational Interviewing (MI) counseling techniques. MI has shown effectiveness with AI, is designed to enhance motivation and is based on the assumption that many people with addictions are not in an advanced state of readiness to change. The goal is to increase motivation by developing a discrepancy between behavior and goals. The study team developed culturally sensitive MI scripts to conduct telephone sessions exploring positive and negative aspects of, ambivalence about and motivation/confidence for quitting, the pros and cons of behavior change, and plans for change. Because previous ANBL participants and facilitators have not believed that MI has been instrumental in participant ability to quit and because some have found it to be burdensome, investigators leave it up to individual sites whether they will use MI or not, tracking use for secondary analyses.
Educational Curriculum: The curriculum includes 11 brochures, given throughout the program; it combines cessation information with cultural elements. Community members have stressed throughout development that cultural issues must be ingrained in the program and its accompanying materials, not given "lip service" by putting AI pictures on "White" materials. These materials were created by the study team and Community Advisory Board (CAB) members, with input from pilot participants, then sent to an AI graphic artist for final layout.
Pharmacotherapy: Current treatment guidelines suggest pharmacotherapy be offered to all smokers making a quit attempt. Study sites may work in conjunction with health centers and pharmacies to provide medication if they so choose; it is not provided as a part of the study. Participants must be under the care of a physician to receive prescription medication. Sites are required to track participant use of medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All community sites will implement the program as most appropriate for their communities.
| Arm | Type | Receives |
|---|---|---|
| All Nations Breath of Life | Experimental | Behavioral: All Nations Breath of LifeANBL is a culturally tailored smoking cessation program that incorporates group-based and individual counseling. Participants may elect to take pharmacotherapy, but are not required to do so. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identified American Indian or allowed to enroll by community site
- Age 18 or older
- Smokes at least one cigarette per day
- Planning to quit smoking
- Have a home address and telephone number
Key exclusion criteria (1 listed)
- Any of the above do not apply
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 |
|---|---|---|
| All Nations Breath of LifeSame. | Behavioural | All Nations Breath of Life |
Primary outcome
Smoking Cessation
Time frame: 7-day point prevalence abstinence at 6 months
Cessation measured by self-report and expired Carbon Monoxide (CO)
1 secondary outcome
Smoking Cessation 2
Time frame: 30-day point prevalence and continuous abstinence at 6 months
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Christine M Daley, PhD principal investigator
Lehigh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All Nations Breath of Life in people with Smoking Cessation, run by Lehigh 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 7 inclusion and 1 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 29 Jun 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?
Smoking Cessation (time frame: 7-day point prevalence abstinence at 6 months). 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 29 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.