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| ID | Type | Description | Link |
|---|---|---|---|
| OCR30384 | Other Identifier | UF OnCore | |
| 1K01DA052673-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxycodone (5mg) + intranasal oxytocin (48 IU) | Active Comparator | Combined effects of oxycodone and oxytocin |
|
| Oral oxycodone (5mg) + intranasal placebo | Active Comparator | 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 |
|
| oxytocin+placebo | Active Comparator | 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 |
|
| placebo+placebo | Sham Comparator | Serves as the control |
|
| Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU) | Active Comparator | Combined effects of oxycodone and oxytocin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyCODONE 5 mg Oral Tablet | Drug | Oral oxycodone 5 mg orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject-rated abuse liability | 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. | up to 6 weeks. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Nieder | Contact | 352-294-1067 | lauren.nieder@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Meredith Berry, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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This is a within-participant study so that each participant receives all conditions.
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| Oral oxycodone (2.5mg) + intranasal placebo | Active Comparator | 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 |
|
| Oxytocin nasal spray | Drug | Intranasal oxytocin administration (48 IU) |
|
| Placebo Oxycodone | Other | Oxycodone 0 mg orally |
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| Placebo oxytocin | Other | Intranasal placebo administration |
|
| OxyCODONE 2.5 mg Oral Tablet | Drug | Oral oxycodone 2.5 mg orally |
|
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |