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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: Completed Phase 1 study of Methamphetamine Use Disorder and Cardiovascular Abnormalities, sponsored by San Francisco Department of Public Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
QT interval associated with combined use of methamphetamine and mirtazapine with and without concomitant methadone use
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2024-05-31 |
| Phase | Phase 1 |
What the finished NCT04614584 record still lists
NCT04614584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 54-participant average among 12 other Methamphetamine Use Disorder trials with a reported enrollment target (72% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Methamphetamine Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04614584's enrollment target sits among peer trials
15 10th of 12 higher than 3 of 12 other Methamphetamine Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Methamphetamine Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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