DRUG
OxyCODONE 5 mg Oral Tablet
Oxycodone 5mg oral administration
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
Status
Recruiting
Phase
Early Phase 1
Enrollment
45
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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, we will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.
Full detailed description
The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, and experimental pain. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.
Interventions
Treatment arms and agents.
DRUG
OxyCODONE 2.5 mg Oral Tablet
Oxycodone 2.5mg oral administration
OTHER
Placebo oxyCODONE Oral Tablet
Oxycodone 0mg (placebo) oral administration
DRUG
Oxytocin Nasal Spray (48 IU)
Intranasal oxytocin administration (48 IU)
OTHER
Placebo Oxytocin Nasal Spray
Intranasal oxytocin placebo administration
Timeline
From registration to results.
First posted
Mar 9, 2023
Study start
Sep 12, 2023
Primary completion
Dec 2026
Study completion
Jul 2027
Results posted
Not reported
Registry updated
May 1, 2026
Outcomes
What the study measures.
Primary outcomes
Subject-rated abuse liability
Time frame · Up to 6 weeks
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 6 sessions due to a minimum of a one week washout period in between each session.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 45 Years
- Maximum age
- 85 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Individuals fluent in English will participate. * Must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime). * Be within 20% of their ideal body weight. * Are not currently experiencing chronic pain (pain on most days during the past 3 months) * Have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute. * Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications. Exclusion Criteria: * Significant current physical disease or major (uncontrolled) psychiatric disorder. * No self-reported current interest in drug abuse treatment. * Women who are pregnant or nursing. * Any severe comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Florida
Gainesville, Florida, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Oxytocin.
NCT IDStudyPhase / statusEnrollmentUpdated
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Wake Forest University Health Sciences · Total Hip Arthroplasty
Phase 2
Enrolling by invitation
80
2026-07
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Yale University · Pain · Pituitary Surgery
Phase 2
Not yet recruiting
75
2026-07
Oxytocin to Enhance Integrated Treatment for AUD and PTSD
Medical University of South Carolina · PTSD · Alcohol Use Disorder
Phase 2
Completed
175
2026-07
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
University Hospital, Tours · Cervical Ripening · Unfavorable Cervix
Phase 3
Recruiting
1,494
2026-07
Different Medications to Induce Labor
Icahn School of Medicine at Mount Sinai · Pregnancy · Labor
Phase 3
Recruiting
281
2026-07
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
Aalto University · Induction of Birth · Cervical Ripening
Not applicable
Recruiting
40
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.