NCT04590404

Metabolism Informed Smoking Treatment: The MIST RCT

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Smoking

Interventions

Type	Name	Description
BEHAVIORAL	Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.	Automated calls to assess smoking status, medication use, and additional support for quit attempt.
DRUG	Nicotine Replacement Therapy	FDA-approved forms of nicotine replacement therapy for smoking cessation.
DRUG	Varenicline	FDA-approved smoking cessation medication.
OTHER	Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)	Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.

Timeline

• Start date: 2020-11-17
• Primary completion: 2024-05-20
• Completion: 2024-11-22
• First posted: 2020-10-19
• Last updated: 2025-12-05
• Results posted: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study