Methamphetamine use disorder affects about 7.4 million people worldwide, yet there is no FDA-approved treatment for this disorder. Mirtazapine, a tetracyclic antidepressant that modulates dopamine by binding serotonin receptors and blocks a2-adrenergic receptors, represents a promising candidate for treating methamphetamine use disorder. A phase 3, parallel-group, double-blind, placebo-controlled randomized clinical trial of 344 adults with methamphetamine use disorder was conducted to establish the safety and efficacy of mirtazapine. The clinical trial found that 12 weeks of mirtazapine dosed at 30 mg/day was associated with a greater reduction in the number of days of methamphetamine use than placebo. More participants in the mirtazapine group reported excess drowsiness and weight gain, but no unexpected safety concerns were noted. These findings confirm that mirtazapine is safe and effective for use in clinical practice to reduce methamphetamine use.
Reference:
McKetin R et al. JAMA Psychiatry 2026. Abstract