Pain
Conditions
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, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.
Detailed description
The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, experimental pain, and to describe the neurobehavioral mechanisms underlying interindividual differences in these effects. 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 MRI eligibility and drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.
Interventions
Oral oxycodone 5 mg orally
DRUGOxytocin nasal spray
Intranasal oxytocin administration (48 IU)
OTHERPlacebo Oxycodone
Oxycodone 0 mg orally
OTHERPlacebo oxytocin
Intranasal placebo administration
Oral oxycodone 2.5 mg orally
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
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals fluent in English will participate. * Must report recreational use of opioids. * 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 psychiatric disorder. * No self-reported current interest in drug abuse treatment. * Women who are pregnant or nursing. * Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine. * Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.
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 4 sessions due to a minimum of a one week washout period in between each session. |
Countries
United States
Contacts
Primary ContactLauren Nieder
Outcome results
None listed