Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation (Aniqsaaq)

March 14, 2025 updated by: Christi Patten, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

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 Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.
  • 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.

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Phases 1 and 2
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.
Behavioral: Phases 1 and 2
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.

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 confirmed, 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

Helpful Links

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)

November 1, 2022

Primary Completion (Actual)

April 28, 2024

Study Completion (Actual)

April 28, 2024

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-000513
  • 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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