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Completed

NCT Number: NCT04590404

Metabolism Informed Smoking Treatment: 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Therapy

Drug

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

Varenicline

Drug

FDA-approved smoking cessation medication.

Other names: Chantix

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.

Primary outcomes

  1. Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence

    Time frame: 6 months

Secondary outcomes

  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

    Participants taking any stop-smoking medications in past 7 days at 1 AND/OR 3 month surveys, also includes those who reported completing their course of medication at 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

    Randomized participants who reported having an office visit with PCP or regular healthcare provider and reported receiving a medication recommendation or prescription (since study enrollment; 1, 3, 6, or 12 months). Some participants may have reported receiving more than 1 prescription over the course of the 12 months.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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