Smoking CessationAniqsaaqNCT05413265
Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation
A study testing Phases 1 and 2 in people with Smoking Cessation, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of the proposed study is to develop and beta-test a culturally adapted, Alaska Native family-based incentives intervention for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Phases 1 and 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Index Participants will be eligible if they:
- Are an ANAI person (based on self-reported race/ethnicity) and reside in Alaska.
- Are aged ≥ 18 years (legal smoking age in Alaska).
- Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 n/ml (positive Alere iScreen result) for Phase 2.
- Smoked ≥ 3 cigarettes per day (cpd) over the past 3 months.
- If other tobacco or nicotine product used, cigarettes are the main tobacco product used.
Show all 21Show fewer
- Are considering or willing to make a quit attempt.
- Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad mini for the study duration.
- Nominate one adult family member who will enroll.
- Index Participants Exclusion Criteria:
- Used pharmacotherapy or a stop smoking program within the past 3 months.
- Another person in the household is enrolled as the index participant.
- Smokes marijuana at least once a week and not willing to quit for study (interferes with breath test) in Phase 2
- Family Member Participants, regardless of smoking status or residence with the index participant, will be eligible if they:
- Are ≥ 18 years old.
- Are defined as family by the index participant.
- Own or have access to a mobile phone or tablet with internet and text messaging capabilities or will be loaned an iPad mini for the study duration.
- Both men and women and those from non-ANAI racial/ethnic groups.
- Family members may only support one index participant.
- Alaska Tribal Health System stakeholders (Phase 1 only):
- Input from healthcare providers, cessation specialists, and THO leaders will be gathered to understand potential facilitators and barriers to adoption of the intervention within the ATHS. The ANTHC team will invite individuals to participate through phone and email communications.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation: Phases 1 and 2
The objective of the proposed study is to develop and beta-test a culturally adapted, Alaska Native family-based incentives intervention for smoking cessation.
Read the detailed description
Aim 1 has two phases:
In Aim 1/Phase 1, we will use qualitative in-depth individual interviews to culturally tailor and adapt the intervention. These interviews (n=36) will include Alaska Native or American Indian (AN/AI) people who smoke (n=12), family members of Alaska Native people who smoke (n=12), and stakeholders from the Alaska Tribal Health System (n=12). We will present the proposed financial incentives intervention to each group and ask them questions about possible concerns, recruitment strategies, possible risks, and appeal to Alaska Native culture. For the stakeholders, we will also ask about potential barriers of implementing the program into their organization/department.
In Aim 1/Phase 2, we will beta-test and refine the intervention with 10 dyads comprising of an AN/AI person who smokes and their family member. The beta-test will last for 6 months. The dyad will receive cash rewards of increasing value over the course of the 6 months for negative, completed smoking status checks. A negative check-in counts as self-reported abstinence and biochemically confirmed abstinence: saliva cotinine sample measuring ≤ 30 n/ml (negative Alere iScreen result) and expired carbon monoxide sample measuring ≤ 6 ppm with iCOQuit device.
- Conditions
- Smoking Cessation
- Being tested
- Phases 1 and 2
- Keywords
- Alaska Native, Smoking Cessation, Family, Financial Incentive
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phases 1 and 2Behavioural
Phase 1 participants will help inform the cultural adaptation of the study design and materials. Phase 2 will enroll 10 dyads (20 individuals) of AN/AI people who smoke and a family member. Dyad participants will help beta-test the feasibility and acceptability of the financial incentives intervention.
| Study group | Role | What they receive |
|---|---|---|
| Phases 1 and 2 | Other | Phase 1 participants will help inform the cultural adaptation of the study design and materials. Phase 2 will enroll 10 dyads (20 individuals) of AN/AI people who smoke and a family member. Dyad participants will help beta-test the feasibility and acceptability of the financial incentives intervention. Receives: Behavioral: Phases 1 and 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in smoking status
Number of participants to have biochemically confirmed, prolonged smoking abstinence
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Nov 2022
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Alaska Native Tribal Health Consortium
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
- Investigators
- Christi A Patten, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413265
- Sponsor's protocol ID
- 22-000513
- Other IDs
- 1R01DA056469-01A1
- Acronym
- Aniqsaaq
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129. eCollection 2023 Jun.
PubMed 37091507Sinicrope PS, Tranby BN, Young AM, Koller KR, King DK, Lee FR, Sabaque CV, Prochaska JJ, Borah BJ, Decker PA, McDonell MG, Stillwater B, Thomas TK, Patten CA. Adapting a Financial Incentives Intervention for Smoking Cessation With Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study. Nicotine Tob Res. 2024 Sep 23;26(10):1377-1384. doi: 10.1093/ntr/ntae092.
PubMed 38642396
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation: Phases 1 and 2
- ClinicalTrials.gov ID
- NCT05413265
- Acronym / sponsor ID
- Aniqsaaq / 22-000513
- Conditions
- Smoking Cessation
- Keywords
- Alaska Native, Smoking Cessation, Family, Financial Incentive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Alaska Native Tribal Health Consortium
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 10 Jun 2022 (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 objective of the proposed study is to develop and beta-test a culturally adapted, Alaska Native family-based incentives intervention for smoking cessation.
Detailed description
Aim 1 has two phases:
In Aim 1/Phase 1, we will use qualitative in-depth individual interviews to culturally tailor and adapt the intervention. These interviews (n=36) will include Alaska Native or American Indian (AN/AI) people who smoke (n=12), family members of Alaska Native people who smoke (n=12), and stakeholders from the Alaska Tribal Health System (n=12). We will present the proposed financial incentives intervention to each group and ask them questions about possible concerns, recruitment strategies, possible risks, and appeal to Alaska Native culture. For the stakeholders, we will also ask about potential barriers of implementing the program into their organization/department.
In Aim 1/Phase 2, we will beta-test and refine the intervention with 10 dyads comprising of an AN/AI person who smokes and their family member. The beta-test will last for 6 months. The dyad will receive cash rewards of increasing value over the course of the 6 months for negative, completed smoking status checks. A negative check-in counts as self-reported abstinence and biochemically confirmed abstinence: saliva cotinine sample measuring ≤ 30 n/ml (negative Alere iScreen result) and expired carbon monoxide sample measuring ≤ 6 ppm with iCOQuit device.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phases 1 and 2 | Other | Behavioral: Phases 1 and 2Phase 1 participants will help inform the cultural adaptation of the study design and materials. Phase 2 will enroll 10 dyads (20 individuals) of AN/AI people who smoke and a family member. Dyad participants will help beta-test the feasibility and acceptability of the financial incentives intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Are an ANAI person (based on self-reported race/ethnicity) and reside in Alaska.
- Are aged ≥ 18 years (legal smoking age in Alaska).
- Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 n/ml (positive Alere iScreen result) for Phase 2.
- Smoked ≥ 3 cigarettes per day (cpd) over the past 3 months.
- If other tobacco or nicotine product used, cigarettes are the main tobacco product used.
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 |
|---|---|---|
| Phases 1 and 2Phase 1 participants will help inform the cultural adaptation of the study design and materials. Phase 2 will enroll 10 dyads (20 individuals) of AN/AI people who smoke and a family member. Dyad participants will help beta-test the feasibility and acceptability of the financial incentives intervention. | Behavioural | Phases 1 and 2 |
Primary outcome
Change in smoking status
Time frame: 6 months, 12 months
Number of participants to have biochemically confirmed, prolonged smoking abstinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 37091507Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129. eCollection 2023 Jun.
- Results publication: PubMed 38642396Sinicrope PS, Tranby BN, Young AM, Koller KR, King DK, Lee FR, Sabaque CV, Prochaska JJ, Borah BJ, Decker PA, McDonell MG, Stillwater B, Thomas TK, Patten CA. Adapting a Financial Incentives Intervention for Smoking Cessation With Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study. Nicotine Tob Res. 2024 Sep 23;26(10):1377-1384. doi: 10.1093/ntr/ntae092.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Christi A Patten, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phases 1 and 2 in people with Smoking Cessation, run by Mayo Clinic 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 21 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: finished, as of the sponsor's last update on 18 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in smoking status (time frame: 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413265, which also lists 2 linked publications.
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 18 Mar 2025.