Opioid Drug Interaction Study

Conditions

• Drug Interactions
• Drug Kinetics

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 1, 2025

Status verified

May 2026

Primary completion

Jan 1, 2029

Completion

Jun 1, 2029

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Arms

• Placebo Comparator: Placebo / Placebo
  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).
• Experimental: Placebo / Oxycodone low oral dose (Percocet, Roxicodone)
  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).
• Experimental: Placebo / Oxycodone high oral dose (Percocet, Roxicodone)
  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).
• Experimental: Alprazolam low oral dose (Xanax) / Placebo
  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).
• Experimental: Alprazolam high oral dose (Xanax) / Placebo
  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).
• Experimental: Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)
  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).
• Experimental: Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)
  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).
• Experimental: Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)
  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).
• Experimental: Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)
  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).

Primary Outcome Measure

Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking [ 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). ]

Central Contacts

• Paul A Nuzzo
  (859) 323-0002
  [email protected]

Locations (1)

Find similar trials in Lexington, KY

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