Alprazolam + Oxycodone for Drug Interaction

Recruiting in Palo Alto (17 mi)

Overseen byShanna Babalonis, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Shanna Babalonis, PhD

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals who can safely take opioids and benzodiazepines, specifically oxycodone and alprazolam. Participants should be interested in how these drugs interact with each other. The study excludes those with allergies to the drugs being tested, current drug abuse issues, or any health conditions that might interfere with the study's safety or outcomes.

Inclusion Criteria

Self-reported opioid use

English-speaking and literate participants, able to understand and sign Informed Consent Document

I am between 18 and 55 years old.

+6 more

Exclusion Criteria

Clinically significant abnormal ECG (as determined by study physician/cardiologist)

I have a chronic condition like high blood pressure or diabetes that needs daily medication.

I need medical help to manage my addiction to alcohol or drugs.

+7 more

Participant Groups

The study is testing how oxycodone (an opioid) interacts with alprazolam (a benzodiazepine). Some participants will receive the actual drugs while others will get a placebo. Researchers are looking at both subjective effects like drug liking and objective measures from blood tests to understand this interaction.

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Placebo / Oxycodone low oral dose (Percocet, Roxicodone)Experimental Treatment2 Interventions

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).

Group II: Placebo / Oxycodone high oral dose (Percocet, Roxicodone)Experimental Treatment2 Interventions

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).

Group III: Alprazolam low oral dose (Xanax) / PlaceboExperimental Treatment2 Interventions

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).

Group IV: Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)Experimental Treatment2 Interventions

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).

Group V: Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)Experimental Treatment2 Interventions

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).

Group VI: Alprazolam high oral dose (Xanax) / PlaceboExperimental Treatment2 Interventions

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).

Group VII: Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)Experimental Treatment2 Interventions

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).

Group VIII: Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)Experimental Treatment2 Interventions

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).

Group IX: Placebo / PlaceboPlacebo Group1 Intervention

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).