NCT06757140

Opioid Drug Interaction Study

Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Shanna Babalonis, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Drug Interactions
• Drug Kinetics

Interventions

Type	Name	Description
DRUG	Alprazolam	Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
DRUG	Oxycodone	Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
DRUG	Placebo	Participants will receive inactive oral doses

Timeline

• Start date: 2025-04-01
• Primary completion: 2029-01-01
• Completion: 2029-06-01
• First posted: 2025-01-03
• Last updated: 2025-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study