The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
Purpose
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.
Condition
- Pain
Eligibility
- Eligible Ages
- Between 45 Years and 85 Years
- Eligible Genders
- All
- Accepts 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 Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- This is a within-participant study so that each participant receives all conditions.
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Oral oxycodone (5mg) + intranasal oxytocin (48 IU) |
Combined effects of oxycodone and oxytocin. |
|
|
Active Comparator Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU) |
Combined effects of oxycodone and oxytocin. |
|
|
Active Comparator Oral placebo + intranasal oxytocin (48 IU) |
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. |
|
|
Active Comparator Oral oxycodone (5mg) + intranasal placebo |
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. |
|
|
Active Comparator Oral oxycodone (2.5mg) + intranasal placebo |
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. |
|
|
Sham Comparator Oral placebo + intranasal placebo |
Serves as the control. |
|
Recruiting Locations
University of Florida
Gainesville, Florida 32611
Gainesville, Florida 32611
More Details
- NCT ID
- NCT05761860
- Status
- Recruiting
- Sponsor
- University of Florida
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.