CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 606 enrolled
Drug / intervention
Nicotine Replacement Therapy +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04590404
NCT04590404Phase 3Completed

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

Vanderbilt-Ingram Cancer Center·interventional·Posted Oct 19, 2020·Updated Dec 5, 2025

In Brief

A Phase 3 clinical trial evaluating Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach., Nicotine Replacement Therapy, and 2 other interventions for Smoking. Completed, enrolled 606 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartNov 17, 2020
Primary CompletionMay 20, 2024
Study CompletionNov 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.7 years ago

Interventions

Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.behavioral

Automated calls to assess smoking status, medication use, and additional support for quit attempt.

Nicotine Replacement Therapydrug

FDA-approved forms of nicotine replacement therapy for smoking cessation.

Vareniclinedrug

FDA-approved smoking cessation medication.

Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)other

Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.