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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
25
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Participants will receive inactive oral doses
University of Kentucky
Lexington, Kentucky, United States
RECRUITINGChange 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.
Time frame: 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).
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.
Time frame: 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).
Change in Respiration Rate
Respiration rate monitored throughout each session. Raw data transformed to trough scores.
Time frame: 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.
Time frame: 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.
Time frame: Oxygen Saturation 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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