Metabolism Informed Smoking Treatment: The MIST RCT

Vanderbilt University Medical Center

Status and phase: Active, not recruiting; Phase 3

Conditions: Smoking

Treatments: Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.; Drug: Nicotine Replacement Therapy; Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy); Drug: Varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04590404

5R01CA232516-03 (U.S. NIH Grant/Contract)

VICC THO 2046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 608 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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608 participants in 2 patient groups

MIST (Metabolism-Informed Smoking Treatment)

Experimental group

Description:

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.

Treatment:

Drug: Varenicline

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

Drug: Nicotine Replacement Therapy

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

Usual Care

Active Comparator group

Description:

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.

Treatment:

Drug: Varenicline

Drug: Nicotine Replacement Therapy

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