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

Smoking Cessation Clinical Trial

— Aniqsaaq  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05413265
• Other study ID #: 22-000513
• Secondary ID: 1R01DA056469-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 31, 2027

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the proposed study is to evaluate the effectiveness and implementation of a culturally adapted, Alaska Native family-based incentives intervention for smoking cessation.

Description:

We will conduct the research in three 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.

In Aims 2 and 3/Phase 3, we will conduct an RCT and evaluate intervention effectiveness and implementation. The RCT will include 656 dyads of AN/AI people who smoke and their family member.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Phases 2 and 3.

• 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 Phases 2 and 3

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 to mitigate concern about lack of independence of household or other support networks, and potential for cross treatment contamination, which could attenuate effects in the RCT.

Alaska Tribal Health System stakeholders:

• 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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Written cessation & support materials
Resources and referral information on evidence-based tobacco/nicotine cessation treatment services
• Financial Incentive
Cash rewards for achieving biochemically verified smoking abstinence at each time point

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Alaska Native Tribal Health Consortium, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in smoking status	Number of participants to have biochemically confirmed, prolonged smoking abstinence	6 months, 12 months