Metabolism Informed Smoking Treatment: The MIST RCT

• ClinicalTrials.gov Identifier: NCT04590404
• Recruitment Status: Recruiting
• First Posted: October 19, 2020
• Last Update Posted: February 16, 2022
• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Information provided by (Responsible Party): Hilary Tindle, Vanderbilt-Ingram Cancer Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Smoking	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)	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT
• Actual Study Start Date: November 17, 2020
• Estimated Primary Completion Date: November 2025
• Estimated Study Completion Date: November 2026

Arms and Interventions

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 Name: 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 Name: Chantix

Outcome Measures

Primary Outcome Measures :

1. Biochemically-validated past 7-day point prevalence tobacco abstinence [ Time Frame: 6 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

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

Contacts and Locations

Contacts

Contact: Paula Harlow; 615-875-4251; paula.a.harlow@vumc.org

Contact: Stephen M King; 615-875-9495; stephen.king@vumc.org

Locations

United States, Tennessee

Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450; Recruiting

Nashville, Tennessee, United States, 37203

Contact: Karen Gilliam 615-936-6668 karen.gilliam@vumc.org

Principal Investigator: Hilary Tindle, MD, MPH

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Hilary Tindle, MD, MPH; Vanderbilt University Medical Center

More Information

• Responsible Party: Hilary Tindle, Investigator, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT04590404
• Other Study ID Numbers: VICC THO 2046; 5R01CA232516-02 ( U.S. NIH Grant/Contract )
• First Posted: October 19, 2020
• Last Update Posted: February 16, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Nicotine; Varenicline; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action