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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DA056813-02 | 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, we will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral oxycodone (5mg) + intranasal oxytocin (48 IU) | Active Comparator | Combined effects of oxycodone and oxytocin. |
|
| Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU) | Active Comparator | Combined effects of oxycodone and oxytocin. |
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| Oral placebo + intranasal oxytocin (48 IU) | 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. |
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| 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. |
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| Oral oxycodone (2.5mg) + intranasal placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyCODONE 5 mg Oral Tablet | Drug | Oxycodone 5mg oral administration |
|
| 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 6 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 E Nieder, MSPH | Contact | (352) 294-1067 | lauren.nieder@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Meredith S 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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This is a within-participant study so that each participant receives all conditions.
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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. |
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| Oral placebo + intranasal placebo | Sham Comparator | Serves as the control. |
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| OxyCODONE 2.5 mg Oral Tablet | Drug | Oxycodone 2.5mg oral administration |
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| Placebo oxyCODONE Oral Tablet | Other | Oxycodone 0mg (placebo) oral administration |
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| Oxytocin Nasal Spray (48 IU) | Drug | Intranasal oxytocin administration (48 IU) |
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| Placebo Oxytocin Nasal Spray | Other | Intranasal oxytocin placebo administration |
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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 |
| 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 |
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