Clinical trial NCT05761860: The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
Official title: The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Pain
Abuse liability
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-03-09
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a within-participant study so that each participant receives all conditions.
Primary purpose: BASIC_SCIENCE

Brief 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, 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.

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.

Primary outcomes:
measure: Subject-rated abuse liability
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Meredith S Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References: