Metabolism Informed Smoking Treatment: The MIST RCT

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

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 Overview

• Status: Active, not recruiting
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.; Drug: Nicotine Replacement Therapy; Drug: Varenicline; Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)

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.

• Study Type: Interventional
• Enrollment (Actual): 608
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Paula Harlow; Phone Number: 615-875-4251; Email: paula.a.harlow@vumc.org
• Study Contact Backup: Name: Stephen M King; Phone Number: 615-875-9495; Email: stephen.king@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIST (Metabolism-Informed Smoking Treatment); At hospital discharge, participants randomized to the MIST precision care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescriptions will be informed by nicotine metabolism (i.e., NMR result) such that faster metabolizers are prescribed varenicline and slower metabolizers are prescribed NRT.	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 Names: Chantix; 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.
Active Comparator: Usual Care; At hospital discharge, participants randomized to the Usual Care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescription will not be informed by nicotine metabolism.	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 Names: Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biochemically-validated past 7-day point prevalence tobacco abstinence	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Biochemically-validated past 7-day point prevalence tobacco abstinence	12 months
Self-reported medication adherence over the past 7 days	1, 3 months
Self-reported receipt of prescription for smoking cessation medication subsequent to the initial study medication prescription	Up to 12 months after hospital discharge
Proportion of prescriptions reported in #3 matched to NMR result	Up to 12 months after hospital discharge
[Exploratory] Healthcare composite outcome consisting of hospitalization, emergency department visit, and/or death within 12 months	12 month period after hospital discharge

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Hilary Tindle, MD, MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine; Varenicline
• Other Study ID Numbers: VICC THO 2046; 5R01CA232516-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No