Family-Based Financial Incentives Intervention for Smoking Cessation (Aniqsaaq-RCT)

February 3, 2026 updated by: Christi Patten, Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Native Tribal Health Consortium
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rewards Group
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.
Behavioral: Financial Incentive Rewards
Participants in the Rewards Group will have abstinence reinforced through escalating financial incentives.
No Intervention: Comparison Group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in smoking status
Time Frame: 6 months, 12 months
Number of participants to have biochemically verified, prolonged smoking abstinence.
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Drug Abuse (NIDA)
Alaska Native Tribal Health Consortium

Investigators

  • Principal Investigator: Christi A Patten, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-04-015
  • 1R01DA056469-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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