Health TrialsbyHealthPanel

Opioid Drug Interaction Study

ConditionsDrug InteractionsDrug Kinetics
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanna Babalonis, PhD

About 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 does not accept healthy volunteers

Qualifiers

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

Disqualifiers

physical dependence on alcohol, opioids, benzodiazepines or sedative/hypnotics requiring medical management/detoxification

seeking treatment for opioid or any other drug use

acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders [e.g., asthma, COPD])

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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

Treatment groups

25 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Placebo / PlaceboPlacebo comparator 1 intervention
Group B: Placebo / Oxycodone low oral dose (Percocet, Roxicodone)Experimental treatment 2 interventions
Group C: Placebo / Oxycodone high oral dose (Percocet, Roxicodone)Experimental treatment 2 interventions
Group D: Alprazolam low oral dose (Xanax) / PlaceboExperimental treatment 2 interventions
Group E: Alprazolam high oral dose (Xanax) / PlaceboExperimental treatment 2 interventions
Group F: Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)Experimental treatment 2 interventions
Group G: Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)Experimental treatment 2 interventions
Group H: Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)Experimental treatment 2 interventions
Group I: Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change 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).

Secondary outcomes

1

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).
2

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).
3

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).
4

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanna Babalonis, PhD

Lead sponsor

University of Kentucky

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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