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Mirtazapine and Methamphetamine Drug-drug Interaction Study

NCT04614584 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-27

No results posted yet for this study

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).

Conditions

  • Methamphetamine Use Disorder
  • Drug Interaction
  • Cardiovascular Abnormalities

Interventions

DRUG

Mirtazapine

Mirtazapine 30 mg PO daily x 4 days

DRUG

Methamphetamine

Methamphetamine 30 mg IV once

Sponsors & Collaborators

Principal Investigators

  • Phillip Coffin, MD, MIA · Director, Substance Use Division, San Francisco Department of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614584 on ClinicalTrials.gov