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NCT04614584
Mirtazapine and Methamphetamine Drug-drug Interaction Study
Phase 1 trial testing Mirtazapine in Methamphetamine Use Disorder in 15 participants. Completed in 31 May 2024.
31 May 2024
Quick facts
| Lead sponsor | San Francisco Department of Public Health |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 3 May 2021 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 May 2024 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Mirtazapine — full drug profile →
- Methamphetamine (METHAMPHETAMINE) — full drug profile →
Conditions studied
- Methamphetamine Use Disorder — all drugs for Methamphetamine Use Disorder →
- Drug Interaction — all drugs for Drug Interaction →
- Cardiovascular Abnormalities — all drugs for Cardiovascular Abnormalities →
Sponsor
San Francisco Department of Public Health
Who can join
18 and older, any sex, with Methamphetamine Use Disorder or Drug Interaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety of Intravenous Methamphetamine in Patients Taking Mirtazapine: A Two-Site Phase 1b Randomized Controlled Trial.
Black F, Santos GM, McMahan VM, Fraser A, et al · · 2026 · PMID 41779519 · DOI 10.1097/jcp.0000000000002148
Verify or expand the search:
- PubMed search for NCT04614584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Methamphetamine Use Disorder
Currently open trials in the same condition.
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- NCT07459244 — ECG Findings in Methamphetamine Use · recruiting
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Other San Francisco Department of Public Health trials
Trials by the same sponsor.
- NCT07219082 — Behavioral Safety and Fentanyl Education: BSAFE · NA · not yet recruiting
- NCT07204249 — Glutide for Ending Methamphetamine · Phase 2 · not yet recruiting
- NCT06076564 — Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose Mortality · completed
- NCT03838510 — Repeated-dose Behavioral Intervention to Reduce Opioid Overdose · NA · completed
- NCT03018353 — Curing HCV in Incarcerated Patients · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04614584 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by San Francisco Department of Public Health
- Last refreshed: 27 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04614584.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing