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Opioid Analgesic

Oxytocin + Oxycodone for Opioid Use Disorder

Phase < 1
Recruiting
Led By Meredith S Berry, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights

Study Summary

This trial will test if combining oxytocin with oxycodone can reduce pain and abuse liability, while improving decision-making.

Who is the study for?
This trial is for English-speaking adults who have used opioids at least once, with normal blood pressure, heart rate, EKG, and bloodwork. They should be near their ideal body weight and not in chronic pain. Excluded are those with severe diseases or psychiatric disorders, pregnant or nursing women, individuals seeking drug abuse treatment, or those with substance use disorders other than nicotine or caffeine.Check my eligibility
What is being tested?
The study tests if oxytocin nasal spray can reduce the addictive potential of oxycodone and enhance its pain relief effects. Participants will undergo six sessions where they'll receive combinations of oxycodone (5 mg or 2.5 mg), placebo tablets, oxytocin spray (48 IU), and placebo sprays to assess their impact on pain response and decision-making.See study design
What are the potential side effects?
Possible side effects may include typical opioid-related issues like nausea, drowsiness, constipation from oxycodone; oxytocin might cause temporary discomfort at the site of nasal application or headaches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subject-rated abuse liability

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: Oral oxycodone (5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions
Combined effects of oxycodone and oxytocin.
Group II: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)Active Control2 Interventions
Combined effects of oxycodone and oxytocin.
Group III: Oral placebo + intranasal oxytocin (48 IU)Active Control2 Interventions
Separate effects of oxytocin. As is standard methodology in abuse liability and pain assessments, a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo.
Group IV: Oral oxycodone (5mg) + intranasal placeboActive Control2 Interventions
Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments, a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo.
Group V: Oral oxycodone (2.5mg) + intranasal placeboActive Control2 Interventions
Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments, a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo.
Group VI: Oral placebo + intranasal placeboPlacebo Group2 Interventions
Serves as the control.

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Who is running the clinical trial?

University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,601 Total Patients Enrolled
19 Trials studying Pain
1,912 Patients Enrolled for Pain
Meredith S Berry, PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

OxyCODONE 2.5 mg Oral Tablet (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05761860 — Phase < 1
Pain Research Study Groups: Oral oxycodone (5mg) + intranasal oxytocin (48 IU), Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU), Oral placebo + intranasal oxytocin (48 IU), Oral oxycodone (5mg) + intranasal placebo, Oral oxycodone (2.5mg) + intranasal placebo, Oral placebo + intranasal placebo
Pain Clinical Trial 2023: OxyCODONE 2.5 mg Oral Tablet Highlights & Side Effects. Trial Name: NCT05761860 — Phase < 1
OxyCODONE 2.5 mg Oral Tablet (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05761860 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being included in the research program?

"According to the trial's eligibility requirements, potential participants should be between 45 and 85 years of age."

Answered by AI

Would I be eligible to enroll in this clinical trial?

"The criteria for inclusion in this trial is that participants must suffer from pain and be between 45 to 85 years old. At present, the medical study seeks to enroll a total of 45 patients."

Answered by AI

How many individuals have signed up for this experiment thus far?

"Affirmative, the clinicaltrials.gov website indicates that this research is actively searching for participants to take part in their experiment. Having been posted on October 1st 2023 and last updated August 30th of the same year, 45 prospective patients are currently sought from a single test centre."

Answered by AI

Are there any remaining openings for participation in this clinical trial?

"According to the information featured on clinicaltrials.gov, enrollment for this trial is still ongoing. It was initially posted on October 1st 2023 and last updated August 30th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I'm retired I like to get out meet people and pickup a few dollars.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
2023. "The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05761860.
All > Oxytocin
~26 spots leftby Mar 2025
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