This phase 3 randomized controlled trial will test Metabolism-Informed Smoking Treatment (MIST), a precision approach to smoking treatment that biologically tailors medication selection to nicotine metabolism.
This is a randomized controlled trial to compare effects of MIST versus usual care (UC) interventions on the outcomes below. Objectives: * Abstinence as defined by biochemically-verified self-reported 7-day point prevalence abstinence at 6 m (1° study outcome) and 12 m (2° outcome). * Clinical practice implementation as measured by participant self-reported medication adherence at months 1 and 3, self-reported receipt of prescription for smoking cessation medication after hospital discharge, and whether the prescription was tailored to the NMR result. Exploratory Objective: \- Longitudinal assessment of health care utilization visits (ER and hospitalization) for 12 months following hospital discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
606
Automated calls to assess smoking status, medication use, and additional support for quit attempt.
FDA-approved forms of nicotine replacement therapy for smoking cessation.
FDA-approved smoking cessation medication.
Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450
Nashville, Tennessee, United States
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Time frame: 6 months
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
Time frame: 12 months
Self-reported Medication Adherence Over the Past 7 Days
Participants taking any stop-smoking medications in past 7 days at 1 AND/OR 3 month surveys, also includes those who reported completing their course of medication at 3 months.
Time frame: 1, 3 months
Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription
Randomized participants who reported having an office visit with PCP or regular healthcare provider and reported receiving a medication recommendation or prescription (since study enrollment; 1, 3, 6, or 12 months). Some participants may have reported receiving more than 1 prescription over the course of the 12 months.
Time frame: Up to 12 months after hospital discharge
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Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.