Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects
Shanna Babalonis, PhD
Summary
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.
Description
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 pot…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * English-speaking and literate participants, able to understand and sign Informed Consent Document * ages 18 to 55 years old inclusive * BMI of greater than/equal to 17 and approximately less than or equal to 30 * self-reported opioid use * self-reported sedative-like drug use * women of childbearing potential must not be pregnant or breastfeeding at screening and be using an effective form of contraception throughout study participation * otherwise healthy as determined by the medical/research team based on medical history, physical examination, vital signs, laboratory c…
Interventions
- DrugAlprazolam
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
- DrugOxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
- DrugPlacebo
Participants will receive inactive oral doses
Location
- University of KentuckyLexington, Kentucky