Mirtazapine and Methamphetamine Drug-drug Interaction Study
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
This is a drug-drug interaction (DDI) study of mirtazapine for methamphetamine (MA) use
disorder (MUD) to ensure the safety of this medication in the presence of a relevant dose of
MA for people actively-using MA.
Aim 1: To determine if mirtazapine alters the cardiovascular response to IV MA.
Aim 2: To determine if the pharmacokinetics of IV MA are altered by mirtazapine
administration.
Aim 3: To evaluate the above aims in the setting of concomitant administration of methadone.
This study involves two simultaneous within-subject drug-drug interaction studies, each
comprised of 12 participants. A total of 24 subjects will be enrolled who have
methamphetamine use disorder who will be classified into 2 groups: (Group 1: no opioids;
Group 2: opioid use disorder on methadone maintenance). Subjects will be randomized to the
order of mirtazapine and placebo (i.e. one-half will receive mirtazapine first, then placebo;
one-half will receive placebo first, then mirtazapine).