Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)
ConditionSmoking Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSouthcentral Foundation
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Nicotine Metabolite Ratio
Other interventionBlood specimens will be drawn, in clinic, by clinical staff trained in blood collection (e.g., certified medical assistant, nurse). Through regular clinic procedures, lab staff will ship for processing to Quest. Quest uses liquid chromatography tandem mass spectrometry with a limit of detection of 2ng/ml for all analytes and will quantify NMR within 3-6 days of sample arrival. Samples will be consumed during testing. Results of NMR will be returned to primary care providers, and NMR-informed medication recommendations will be made to participants.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Nicotine Metabolite RatioExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of intervention implementation: Enrollment
Proportion of eligible persons who enroll
Time frame
Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks2
Feasibility of intervention implementation: Treatment recommendations
Proportion who use treatment recommended by NMR results
Time frame
Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks3
Feasibility of intervention implementation: Semi-structured interviews
Qualitatively, based on semi-structured interviews with a selection of participants and care team/administrators, thematic analysis will explore barriers and facilitators to using metabolism-informed care, as well as fidelity challenges in adhering to the recommended treatment.
Time frame
Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks4
Acceptability of metabolism-informed intervention: Quantitative
Mean of fourteen, 3-point, Likert-scale survey responses (agree/neither agree nor disagree/disagree, with a "prefer not to answer" option). These items will assess intervention and process acceptability including timeliness of the procedures and recommendation, composition of the team, clarity of communication, ease of understanding pilot measures, willingness to recommend, and satisfaction. These items will be combined into a summary score indicating overall acceptability of the intervention.
Time frame
Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeksSecondary outcomes
1
Smoking Cessation: Self-report
self-report of cigarette smoking for the past 7 days
Time frame
Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks2
Smoking Cessation: Expelled CO
expelled CO\<4ppm according to a handheld breath monitor which connects to a mobile device (iCO Smokerlyzer®, Bedfont Scientific)
Time frame
Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks3
Smoking Cessation: Nicotine <10ng/mL
nicotine \<10ng/mL measured by a saliva test strip (Accutest® NicAlert Saliva Collection Kit)
Time frame
Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Southcentral Foundation
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov