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

NCT05413265 | Completed

• 2 other identifiers: 22-0005131R01DA056469-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Keywords

Alaska Native; Smoking Cessation; Family; Financial Incentive

Outcome Measures

Primary Outcomes (1)

• Change in smoking status

  Number of participants to have biochemically confirmed, prolonged smoking abstinence

  6 months, 12 months

Study Arms (1)

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.

Behavioral: Phases 1 and 2

Interventions

Phases 1 and 2 BEHAVIORAL

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.

Phases 1 and 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Alaska Native Tribal Health Consortium: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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: 37091507 BACKGROUND

• 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: 38642396 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Christi A Patten, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: November 1, 2022
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

US (1)