Pain
Conditions
Keywords
Pain, Abuse liability
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.
Interventions
Oxycodone 5mg oral administration
Oxycodone 2.5mg oral administration
OTHERPlacebo oxyCODONE Oral Tablet
Oxycodone 0mg (placebo) oral administration
DRUGOxytocin Nasal Spray (48 IU)
Intranasal oxytocin administration (48 IU)
OTHERPlacebo Oxytocin Nasal Spray
Intranasal oxytocin placebo administration
Sponsors
National Institute on Drug Abuse (NIDA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a within-participant study so that each participant receives all conditions.
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-rated abuse liability | 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. |
Countries
United States
Contacts
Primary ContactLauren E Nieder, MSPH
Outcome results
None listed