Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT

VICC THO 2046

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.

2020-11-17

2025-11-01

2026-11-01

Active (not recruiting)

Early phase I

608

Inclusion Criteria: * be 18 years or older * be enrolled in an insurance plan that supports prescription coverage for smoking cessation medication (such as Medicare part D, Medicaid, or private insurance) to facilitate bedside delivery of medications prior to hospital discharge * have a regular provider/PCP * agree to quit or try to quit smoking upon hospital discharge * be a daily smoker when smoking normally during the month prior to entering the hospital * be medically eligible to use varenicline * be medically eligible to use nicotine replacement therapy * have received discharge medication recommendations from a tobacco counselor * agree to take smoking cessation medication (i.e., varenicline OR nicotine replacement therapy) home and consider using it * have a cell phone or landline that can be reached directly (i.e., without transfer) * have a permanent address where they live and can receive mail * estimated life expectancy of at least one year or greater Exclusion Criteria: * insufficient time to perform and complete the enrollment process * barrier to effective communication (including low English proficiency) * not cognitively able to participate in the study * too ill, on hospice, or physically unable to participate in the follow-up process * previously completed the MIST study or is currently enrolled in a quit smoking study that involves a medication-based treatment * estimated life expectancy of less than one year

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 608, 'type': 'ACTUAL'}}

2023-11-13