Metabolism Informed Smoking Treatment: The MIST RCT

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04590404
• Other study ID #: VICC THO 2046
• Secondary ID: 5R01CA232516-03
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 17, 2020
• Est. completion date: November 2026

Study information

• Verified date: November 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 608
• Est. completion date: November 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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.
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically-validated past 7-day point prevalence tobacco abstinence		6 months
Secondary	Biochemically-validated past 7-day point prevalence tobacco abstinence		12 months
Secondary	Self-reported medication adherence over the past 7 days		1, 3 months
Secondary	Self-reported receipt of prescription for smoking cessation medication subsequent to the initial study medication prescription		Up to 12 months after hospital discharge
Secondary	Proportion of prescriptions reported in #3 matched to NMR result		Up to 12 months after hospital discharge
Secondary	[Exploratory] Healthcare composite outcome consisting of hospitalization, emergency department visit, and/or death within 12 months		12 month period after hospital discharge