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NCT04614584 · ClinicalTrials.gov registry record · Phase 1

Mirtazapine and Methamphetamine Drug-drug Interaction Study

A Phase 1 study of Methamphetamine Use Disorder and Cardiovascular Abnormalities, sponsored by San Francisco Department of Public Health.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
3
Study locations

NCT04614584 is a Phase 1 study of Methamphetamine Use Disorder and Cardiovascular Abnormalities that has completed, run by San Francisco Department of Public Health. The registered enrollment target is 15 participants, below the 54-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (72% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT04614584, a Phase 1 study of Methamphetamine Use Disorder and Cardiovascular Abnormalities, has completed, sponsored by San Francisco Department of Public Health.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
3
Study locations

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 Studied

Methamphetamine Use Disorder Cardiovascular Abnormalities Drug Interaction

Interventions

  • DRUG Methamphetamine
  • DRUG Mirtazapine

Study Locations (3)

California

  • UCLA Medical Center - Los Angeles
  • San Francisco Department of Public Health - San Francisco
  • Substance Use Research Unit - San Francisco

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-05-03
Est. Completion 2024-05-31
Phase Phase 1

Sponsor

San Francisco Department of Public Health

13 total trials

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What the Registry Record Tells You About NCT04614584

The ClinicalTrials.gov registry entry for NCT04614584 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 54-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (72% lower). The listed sponsor is San Francisco Department of Public Health, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Methamphetamine Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Methamphetamine is the first listed.

NCT04614584 reports 3 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04614584 about?

NCT04614584 is a clinical study titled "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 ...

What is the current status of trial NCT04614584?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2021-05-03. Estimated completion is 2024-05-31.

What conditions does trial NCT04614584 study?

This clinical trial studies the following conditions: Methamphetamine Use Disorder, Cardiovascular Abnormalities, Drug Interaction.

What interventions are being tested in trial NCT04614584?

The interventions under investigation include: Methamphetamine (DRUG), Mirtazapine (DRUG).

Who is sponsoring clinical trial NCT04614584?

This trial is sponsored by San Francisco Department of Public Health, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04614584 being conducted?

This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.