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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA016718 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will examine the effects of doses of opioid/placebo and doses of alprazolam/placebo, alone and in combination. The primary outcomes are pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) and pharmacokinetic outcomes (from blood samples) to determine the interaction effects of these compounds.
Alprazolam (Xanax®) is a short-acting benzodiazepine that is the commonly prescribed in the U.S. (>15 million prescriptions in 2021) and CDC reporting indicates that alprazolam was associated with the greatest increase in number of ED presentations of the benzodiazepines. This study will examine the effects of a widely prescribed and abused mu opioid agonist, oxycodone, and a widely prescribed and abused benzodiazepine, alprazolam, when given alone and in combination to experienced drug using volunteers. Key safety outcomes, including expired CO2, pharmacodynamic measures related to abuse potential, and cognitive/psychomotor performance will be thoroughly examined over a range of doses for both drugs alone and in combination. Pharmacokinetic data will also be collected and analyzed to assess the potential pharmacokinetic interaction as an underlying mechanism of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo / Placebo | Placebo Comparator | Participants will receive 2 drug administrations, neither will be active. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Placebo / Oxycodone low oral dose (Percocet, Roxicodone) | Experimental | Participants will receive 2 drug administrations, one dose oral placebo and one low dose oral oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Placebo / Oxycodone high oral dose (Percocet, Roxicodone) | Experimental | Participants will receive 2 drug administrations, one dose oral placebo and one high dose oral oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Alprazolam low oral dose (Xanax) / Placebo | Experimental | Participants will receive 2 drug administrations, one dose oral placebo and one low dose oral alprazolam. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam | Drug | Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100) with higher scores equating to increased liking. Raw data transformed to peak scores. | This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect | Participants rated their subjective drug effect on a standardized VAS scale (0 to 100) with higher scores equating to increased effect. Raw data transformed to peak scores. | This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul A Nuzzo | Contact | (859) 323-0002 | paul.nuzzo@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shanna Babalonis, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40508 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| D010098 | Oxycodone |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Double-blind
| Alprazolam high oral dose (Xanax) / Placebo | Experimental | Participants will receive 2 drug administrations, one dose oral placebo and one high dose oral alprazolam. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone) | Experimental | Participants will receive 2 non-therapeutic oral drug administrations, one low dose alprazolam, and one low dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone) | Experimental | Participants will receive 2 non-therapeutic oral drug administrations, one high dose alprazolam, and one low dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone) | Experimental | Participants will receive 2 non-therapeutic oral drug administrations, one low dose alprazolam, and one high dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone) | Experimental | Participants will receive 2 non-therapeutic oral drug administrations, one high dose alprazolam, and one high dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr). |
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| Oxycodone | Drug | Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam |
|
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| Placebo | Drug | Participants will receive inactive oral doses |
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| Change in Respiration Rate | Respiration rate monitored throughout each session. Raw data transformed to trough scores. | Respiration rate recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
| Change in End-tidal Carbon Dioxide (EtCO2) | Change in End-tidal Carbon Dioxide (EtCO2) monitored throughout each session. Raw data transformed to peak scores. | End-tidal Carbon Dioxide (EtCO2) recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
| Change in Oxygen Saturation | Oxygen Saturation monitored throughout each session. Raw data transformed to trough scores. | Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
| D006571 | Heterocyclic Compounds |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |