Metabolism Informed Smoking Treatment: The MIST RCT

  • STATUS
    Recruiting
  • End date
    Nov 24, 2026
  • participants needed
    1000
  • sponsor
    Vanderbilt-Ingram Cancer Center
Updated on 4 October 2022

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.

Details
Condition Smoking
Treatment Varenicline, Nicotine Replacement Therapy, Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach., Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
Clinical Study IdentifierNCT04590404
SponsorVanderbilt-Ingram Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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