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drugset / Trial / NCT04590404

Metabolism Informed Smoking Treatment: The MIST RCT

NCT04590404 ↗

Phase 3 Completed 606 enrolled Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-11-17
Primary completion
2024-05-20
Completion
2024-11-22

Outcome

Missed primary endpoint

registry analysis (superiority test); MIST (Metabolism-Informed Smoking Treatment) vs Guideline-Based Care; p = 0.461; Odds Ratio (OR) 1.18 (95% CI 0.76 to 1.82); Regression, Logistic NCT04590404 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Varenicline Small molecule — —

Indications

No indication recorded.