NCT06556433

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,312

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Sep 2024Apr 2028

First Submitted

Initial submission to the registry

August 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

September 3, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

August 13, 2024

Last Update Submit

February 3, 2026

Conditions

Smoking Cessation

Keywords

Alaska NativeFamilyFinancial IncentiveSmoking CessationContingency Management

Outcome Measures

Primary Outcomes (1)

  • Change in smoking status

    Number of participants to have biochemically verified, prolonged smoking abstinence.

    6 months, 12 months

Study Arms (2)

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.

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.

Interventions

Financial Incentive RewardsBEHAVIORAL

Participants in the Rewards Group will have abstinence reinforced through escalating financial incentives.

Rewards Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Already enrolled in the study with another family member.
  • Participated in a prior study phase.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99508, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 37091507BACKGROUND

  • Sinicrope 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.

    PMID: 38642396BACKGROUND

  • Tranby 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.

    PMID: 40224301BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Christi A Patten, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christi A Patten, PhD

CONTACT

507-261-0718patten.christi@mayo.edu

Audrey G McGuinness, BA

CONTACT

1-507-422-5074McGuinness.Audrey@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Behavioral Health Research Program

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 16, 2024

Study Start

September 3, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

US(1)