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Metabolism Informed Smoking Treatment: The MIST RCT

NCT04590404 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2025-12-05

Study results available
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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.

Conditions

  • Smoking

Interventions

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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Hilary Tindle, MD, MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2024-05-20
Completion
2024-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590404 on ClinicalTrials.gov