Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04218409 · ClinicalTrials.gov registry record · Early Phase 1
Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
A Early Phase 1 study of Pain, sponsored by University of Florida.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04218409: Recruiting Early Phase 1 study of Pain, sponsored by University of Florida.
NCT04218409 is a Early Phase 1 study of Pain that is actively recruiting participants, run by University of Florida. The registered enrollment target is 45 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04218409, a Early Phase 1 study of Pain, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.
Primary Outcome
Using a Visual Analog Scale with scoring as 0=not at all, 20=possibly mild, 40=definitely mild, 60=moderately, 80=strongly, and 100=extremely, or any number in between. Testing occurs only in the context of 4 sessions due to a minimum of a one week washout period in between each session.
Conditions Studied
Interventions
- DRUG OxyCODONE 5 mg Oral Tablet
- DRUG Oxytocin nasal spray
- OTHER Placebo Oxycodone
- OTHER Placebo oxytocin
- DRUG OxyCODONE 2.5 mg Oral Tablet
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What NCT04218409 shows while recruiting
NCT04218409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 5 interventions - of which OxyCODONE 5 mg Oral Tablet is the first listed.
NCT04218409 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04218409 about?
NCT04218409 is a clinical study titled "Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination". Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on exper...
What is the current status of trial NCT04218409?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2021-09-02. Estimated completion is 2026-12-31.
What conditions does trial NCT04218409 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT04218409?
The interventions under investigation include: OxyCODONE 5 mg Oral Tablet (DRUG), Oxytocin nasal spray (DRUG), Placebo Oxycodone (OTHER), Placebo oxytocin (OTHER), OxyCODONE 2.5 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04218409?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04218409 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain
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 NCT04218409's enrollment target sits among peer trials
45 272nd of 374 higher than 99 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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
-
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
RECRUITING · Early Phase 1
-
Effects of Dronabinol in Opioid Maintained Patients
RECRUITING · Early Phase 1
-
Remimazolam NeuroImaging
RECRUITING · Early Phase 1
-
Nitrous Oxide Neuroimaging
RECRUITING · Early Phase 1
-
Ketamine and Propofol NeuroImaging
RECRUITING · Early Phase 1
-
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
ACTIVE NOT RECRUITING · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI