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Mirtazapine Modestly Cuts Meth Use in Phase III Trial

With no approved drugs for methamphetamine use disorder, the generic antidepressant offers a small, reproducible benefit that may inform care.

Overview

  • The Tina Trial, a double-blind randomized study in Australian outpatient clinics, tested mirtazapine against placebo in 339 adults with moderate to severe methamphetamine use disorder.
  • Participants taking mirtazapine reduced use by 7 of 28 days on average versus 4.8 days with placebo, a statistically significant difference reported in JAMA Psychiatry.
  • The study found no meaningful change on depression, insomnia, HIV risk behavior, quality of life, or methamphetamine-negative oral fluid tests.
  • Safety results showed expected effects, with higher drowsiness (47% vs 33%), more weight gain (10% vs 3%), and more discontinuations for side effects (23% vs 15%) in the mirtazapine group.
  • Investigators called the effect modest yet clinically notable given the lack of approved medications, and said the results confirm earlier phase II signals and warrant further trials and careful use in routine practice.