Open Actively Recruiting
Mirtazapine and Methamphetamine Drug-drug Interaction Study
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).
- age 18-55 years inclusive;
- meet DSM-V criteria for MA use disorder, as diagnosed via SCID;
- provide MA-positive urine during screening;
- have a resting heart rate of 50-90
- have a systolic blood pressure ≤ of 100-150 mm Hg, and diastolic blood pressure of 45-90 Hg within two days prior to admission;
- have a baseline EKG that demonstrates normal sinus rhythm, QTc < 440 msec in men or QTc < 450 msec in women;
- have acceptable safety lab data, ALT / AST<3x upper limit nL; est GFR >50;
- if female (except females of non-childbearing potential-e.g., at least 1 year post-menopausal or surgically sterile), not pregnant confirmed by negative pregnancy test nor lactating and willing to use a medically approved method of birth control to prevent pregnancy during the trial and for 7 days after the last dose of study medication.
- For those who also use opioids and are on methadone maintenance treatment (Group 2), urine positive for methadone and negative for buprenorphine on admission.
- Have current cocaine, cannabis, or alcohol use disorder by DSM-V SCID;
- current or past history of seizure disorder;
- current ongoing treatment with psychotropic medications (e.g. antidepressants, antipsychotics, antiepileptics, sedative/hypnotics, narcotic analgesics);
- urine positive for MA and other unplanned drugs on the day of admission and breathalyzer results negative for alcohol;
- any prior adverse reaction to MA; including chest pain or epileptic seizure;
- major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar illness but excepting stable major depressive disorder, generalized anxiety disorder, etc.) as assessed by the SCID;
- have a current neurological disorder (e.g., organic brain disease, dementia) or medical condition which would make study compliance difficult or compromise informed consent;
- history of suicide attempt(s) in the past 90 days or current suicidal intent or plan by SCID;
- evidence of untreated or unstable serious medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease including active tuberculosis infection;
- seeking treatment for MA problems at the time of the study;
- any serious medical or psychiatric AE after test infusion of MA 30mg IV (e.g. sustained SBP>200 or DBP>100; sustained pulse >(220-0.85xAge).
- any other circumstances that, in the opinion of the investigators, would compromise participant safety and/or successful completion of the trial.
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