Clinical trial NCT06556238: Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)
Official title: Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT): Pilot Intervention and Assessment of Barriers and Facilitators of Implementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Southcentral Foundation
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to refine and pilot an intervention using the Nicotine Metabolite Ratio (NMR) to inform the selection of pharmacologic treatment to increase smoking abstinence among Alaska Native and American Indian people. This is a single-arm pilot trial to assess and improve acceptability and feasibility.


Eligibility criteria: Inclusion Criteria:

(Patients)

* Alaska Native or American Indian person by self-report
* eligible for or already receiving services at Southcentral Foundation (SCF)
* age 18 years or older
* daily smoking in the past 30-days
* if other nicotine or tobacco products are used, cigarettes are main product used
* planning to schedule an appointment with the Quit Tobacco Program to seek smoking cessation treatment in the next 30 days
* willing to make a quit attempt within 30 days of enrollment in the Quit Tobacco Program
* willing to have a blood test to inform their treatment
* willing to try a pharmacologic treatment
* willing to provide a saliva sample
* has phone service
* has access to broadband internet on mobile phone at home, work, or other location
* has an Android or iPhone mobile phone compatible with the Smokerlyzer app

(Staff)

- Staff participants of qualitative interviews to assess acceptability and feasibility of the intervention must be a health care professional at Southcentral Foundation (SCF), involved in the care of one of the participants of the study, that is their care team staff; including but not limited to: primary care providers, tobacco treatment specialists/health educators, pharmacists, nurse case managers, behavioral health consultants, certified medical assistants, and lab technicians.

Exclusion Criteria:

(Patients)

* Participated in the prior study phase
* participated in a cessation program during the past 3 months
* their provider has not approved varenicline in their referral to the Quit Tobacco Program
* has history of serious hypersensitivity or skin reactions to varenicline
* has bleeding disorder or is currently receiving cancer treatment
* questionable capacity or impaired decision-making capacity

Primary outcomes:
measure: Feasibility of intervention implementation: Enrollment
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
measure: Feasibility of intervention implementation: Treatment recommendations
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
measure: Feasibility of intervention implementation: Semi-structured interviews
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
measure: Acceptability of metabolism-informed intervention: Quantitative
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
measure: Acceptability of metabolism-informed intervention: Qualitative
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Secondary outcomes:
measure: Smoking Cessation: Self-report
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
measure: Smoking Cessation: Expelled CO
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
measure: Smoking Cessation: Nicotine <10ng/mL
timeFrame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Anchorage Native Primary Care Center
state: Alaska
Study officials:
affiliation: Southcentral Foundation
name: Georgia J Michlig, PhD
role: PRINCIPAL_INVESTIGATOR
References: