The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OxyCODONE 5 mg Oral Tablet, OxyCODONE 2.5 mg Oral Tablet, Placebo oxyCODONE Oral Tablet, Oxytocin Nasal Spray (48 IU).
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 45 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
- Drug OxyCODONE 5 mg Oral Tablet
Oxycodone 5mg oral administration - 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
Primary outcome measures
- Subject-rated abuse liability [Time frame: Up to 6 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT05761860 · IRB202300435 · 5R21DA056813-02