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NCT03525509
Epidural Methadone in Healthy Volunteers
EARLY_PHASE1 trial testing Methadone hydrochloride in Pain, Acute in 13 participants. Completed in 30 August 2019.
28 August 2019
Quick facts
| Lead sponsor | simon.haroutounian |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 4 June 2018 |
| Primary completion | 28 August 2019 |
| Estimated completion | 30 August 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Methadone hydrochloride (METHADONE) — full drug profile →
- Morphine Sulfate — full drug profile →
Conditions studied
- Pain, Acute — all drugs for Pain, Acute →
Sponsor
simon.haroutounian
Who can join
18 and older, any sex, with Pain, Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Epidurally administered opioid pain medications are important tools for postoperative pain control, but each agent has its own limitations. Methadone's properties suggest that it may provide a long duration of pain control with minimal side effects related to spread to the brain or absorption into the blood stream. In this study, the investigators aim to compare the relative pain relieving effects, markers of side effects, and concentrations in the blood of epidurally administered methadone as compared to another long-acting opioid which is commonly administered epidurally, morphine.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Epidural methadone and morphine pharmacokinetics and clinical effects in healthy volunteers: A randomized, crossover-design trial.
Hincker A, Reschke M, Ginosar Y, Kagan L, et al · · 2024 · cited 2× · PMID 39049497 · DOI 10.1111/bcp.16178
Verify or expand the search:
- PubMed search for NCT03525509
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Methadone hydrochloride
Trials testing the same drug.
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Other recruiting trials for Pain, Acute
Currently open trials in the same condition.
- NCT07249827 — A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guid · Phase 2 · recruiting
- NCT07053774 — Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain · Phase 2 · recruiting
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- NCT06960317 — Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements · NA · recruiting
- NCT06754657 — CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery · Phase 4 · recruiting
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 NCT03525509 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 simon.haroutounian
- Last refreshed: 18 September 2019
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/NCT03525509.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing