Smoking CessationAniqsaaq-RCTNCT06556433
Family-Based Financial Incentives Intervention for Smoking Cessation
A study testing Financial Incentive Rewards in people with Smoking Cessation, run by Mayo Clinic at 1 site in United States.
Trial summary
The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention. 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?
- Financial Incentive Rewards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,312 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to 30 Apr 2028
- 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
- No healthy volunteers
- Adult, Older adult
Index Participant Inclusion Criteria:
- Alaska Native/American Indian (ANAI) person (based on self-reported race) and reside in Alaska.
- Age ≥18 years.
- Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 ng/mL (positive result based on at-home saliva swab test provided by study team).
- Smoked ≥ 3 cigarettes per day over the past 3 months.
- Considering or willing to make a quit attempt.
- Have or will nominate one adult family member to enroll with them.
- Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration
- Willing to upload photos of self during completion of smoking status tests.
- Willing to complete and sign an Internal Revenue Service (IRS) W-9 tax identification form if they wish to receive payments on the study.
- Willing to provide written informed consent and participate in study-related tests and procedures.
Index Participant Exclusion Criteria:
- Already enrolled in the study with another family member.
- Participated in a prior study phase.
Family Member Participant Inclusion Criteria (regardless of smoking status or residence with the index participant):
- Age ≥18 years.
- Defined as family and nominated by the index participant, or have an ANAI family member who is ≥18 years and smokes that they would like to support in quitting.
- Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration.
- Willing to complete and sign an IRS W-9 tax identification form if they wish to receive payments on the study.
- Willing to provide written informed consent and participate in study related tests and procedures.
Both men and women, those from non-ANAI racial/ethnic groups, and those who live outside of Alaska in the United States will be eligible family member participants.
Family Member Participant Exclusion Criteria:
- Already enrolled with another family member.
- Participated in a prior study phase.
After the randomized controlled trial, qualitative interviews will be conducted with index participants, family member participants, and Alaska Tribal Health System Stakeholders to inform program implementation. Healthcare providers, cessation specialists, Elder advisors, and Tribal Health System leaders and stakeholders will be invited by the Alaska Native Tribal Health Consortium team and separately consented and interviewed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99508
Timothy K Thomas, MD, 907-729-1900, tkthomas@anthc.org
Barb J Stillwater, PhD, 1-907-729-1900, bjstillwater@anthc.org
About this study
Official title: Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation: An RCT
The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.
Read the detailed description
Dyads will be stratified by the index participant's sex, and residence with family member, and by the family member's current smoking status then randomized to a no incentives control condition (n=328 dyads) or a 6-month incentive intervention (n=328 dyads).
All dyads will receive existing evidence-based cessation materials on treatment resources and social support strategies. The study will measure the index participant's smoking status in both study groups weekly during the first four weeks, and at three and six months. All participants, including support persons, will receive incentives when they complete each of the smoking status assessments. The intervention group will additionally receive individual rewards provided to the index participant for achieving verified smoking abstinence at each time point, to a maximum of $750.
The enrolled family member will also receive rewards equivalent to the value earned by the index participant that can contribute to family needs. The study will explore potential moderators (e.g., family member smoking status, index participant's sex) and mediators (e.g., interdependence) of intervention effects.
- Conditions
- Smoking Cessation
- Being tested
- Financial Incentive Rewards
- Keywords
- Alaska Native, Family, Financial Incentive, Smoking Cessation, Contingency Management
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Incentive RewardsBehavioural
Participants in the Rewards Group will have abstinence reinforced through escalating financial incentives.
| Study group | Role | What they receive |
|---|---|---|
| Rewards Group | Experimental | Index participants in the Rewards Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Rewards Group will receive informational materials on smoking cessation. Receives: Behavioral: Financial Incentive Rewards |
| Comparison Group | No intervention | Index participants in the Comparison Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Comparison Group will receive informational materials on smoking cessation. |
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 verified, 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 posted16 Aug 2024
- Study start3 Sep 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,312 participants (estimated)
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
- NCT06556433
- Sponsor's protocol ID
- 2024-04-015
- Other IDs
- 1R01DA056469-01A1
- Acronym
- Aniqsaaq-RCT
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2024
- Last updated
- 10 Aug 2026
- 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 38642396Tranby BN, Young AM, Roche AI, Lee FR, Brown AR, Stillwater BJ, Prochaska JJ, King DK, Decker PA, Borah BJ, McDonell MG, Thomas TK, Patten CA. Beta-testing the feasibility of a family-based financial incentives smoking cessation intervention with Alaska Native families: Phase 2 of the Aniqsaaq (to breathe) Study. Contemp Clin Trials Commun. 2025 Mar 17;45:101472. doi: 10.1016/j.conctc.2025.101472. eCollection 2025 Jun.
PubMed 40224301
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. 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: An RCT
- ClinicalTrials.gov ID
- NCT06556433
- Acronym / sponsor ID
- Aniqsaaq-RCT / 2024-04-015
- Conditions
- Smoking Cessation
- Keywords
- Alaska Native, Family, Financial Incentive, Smoking Cessation, Contingency Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,312 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Alaska Native Tribal Health Consortium
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 16 Aug 2024 (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 current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.
Detailed description
Dyads will be stratified by the index participant's sex, and residence with family member, and by the family member's current smoking status then randomized to a no incentives control condition (n=328 dyads) or a 6-month incentive intervention (n=328 dyads).
All dyads will receive existing evidence-based cessation materials on treatment resources and social support strategies. The study will measure the index participant's smoking status in both study groups weekly during the first four weeks, and at three and six months. All participants, including support persons, will receive incentives when they complete each of the smoking status assessments. The intervention group will additionally receive individual rewards provided to the index participant for achieving verified smoking abstinence at each time point, to a maximum of $750.
The enrolled family member will also receive rewards equivalent to the value earned by the index participant that can contribute to family needs. The study will explore potential moderators (e.g., family member smoking status, index participant's sex) and mediators (e.g., interdependence) of intervention effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rewards Group | Experimental | Behavioral: Financial Incentive RewardsIndex participants in the Rewards Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Rewards Group will receive informational materials on smoking cessation. |
| Comparison Group | No intervention | –Index participants in the Comparison Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Comparison Group will receive informational materials on smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Financial Incentive RewardsParticipants in the Rewards Group will have abstinence reinforced through escalating financial incentives. | Behavioural | Rewards Group |
Primary outcome
Change in smoking status
Time frame: 6 months, 12 months
Number of participants to have biochemically verified, prolonged smoking abstinence.
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 10 Aug 2026.
- 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.
- Background: 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.
- Background: PubMed 40224301Tranby BN, Young AM, Roche AI, Lee FR, Brown AR, Stillwater BJ, Prochaska JJ, King DK, Decker PA, Borah BJ, McDonell MG, Thomas TK, Patten CA. Beta-testing the feasibility of a family-based financial incentives smoking cessation intervention with Alaska Native families: Phase 2 of the Aniqsaaq (to breathe) Study. Contemp Clin Trials Commun. 2025 Mar 17;45:101472. doi: 10.1016/j.conctc.2025.101472. eCollection 2025 Jun.
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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.
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 Financial Incentive Rewards 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?
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: looking for participants now, as of the sponsor's last update on 10 Aug 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?
Contact Christi A Patten, PhD (507-261-0718, patten.christi@mayo.edu), or a site near the patient. 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 NCT06556433, which also lists 3 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 10 Aug 2026.