A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

Study Overview
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Brief Summary
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The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.

Official Title
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A Randomized, Single-Dose, Placebo-Controlled, Double-Blind, 3-Way Crossover Study to Determine the Relative Abuse Potential of Intravenous Oxycodone Hydrochloride Alone or in Combination With Intravenous Naltrexone Hydrochloride in Opioid Experienced Non-Dependent Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: Oxycodone + Naltrexone
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Non-dependent, recreational opioid users Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1). Exclusion Criteria: Diagnosis of substance and/or alcohol dependence Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder History of sleep apnea.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Treatment A<br> | Drug: Placebo<br>* 0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.<br>|
| Experimental: Treatment B<br> | Drug: Oxycodone + Naltrexone<br>* Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.<br>|
| Active Comparator: Treatment C<br> | Drug: Oxycodone<br>* Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Drug Liking: Peak Effect (Emax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| High: Area Under Effect Curve (AUE) From 0-2 Hours | High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| High: Peak Effect (Emax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of | 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| High: Area Under Effect Curve (AUE) From 0-1 Hour | High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| High: Area Under Effect Curve (AUE) From 0-8 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Take Drug Again: Peak Effect (Emax) | Take Drug Again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100-point bipolar VAS with score ranging from 0 mm to 100 (score of 0 = | 12, 24 h post-dose | 
| Take Drug Again: Mean Effect (Emean) |  | 12, 24 h post-dose | 
| Overall Drug Liking: Peak Effect (Emax) | Overall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 = | 12, 24 h post-dose | 
| Overall Drug Liking: Mean Effect (Emean) |  | 12, 24 h post-dose | 
| Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour | Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose | 
| Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour | Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h | 
| Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour | Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h | 
| Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour | Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose | 
| Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Nausea: Area Under Effect Curve (AUE) From 0-1 Hour | Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Nausea: Area Under Effect Curve (AUE) From 0-2 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose | 
| Nausea: Area Under Effect Curve (AUE) From 0-8 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour | Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose | 
| Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour | Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). | pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose | 
| Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Any Drug Effects: Peak Effect (Emax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Good Drug Effects: Peak Effect (Emax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Bad Drug Effects: Peak Effect (Emax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Feel Sick: Peak Effect (Emax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Nausea: Peak Effect (Emax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Sleepy: Peak Effect (Emax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Dizzy: Peak Effect (Emax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants have the size of their pupil measured (in mm) using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. | pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose | 
| Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose | 
| Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose | 
| Pupillometry: Peak Effect (Emax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Pupillometry: Time to Maximum (Peak) Effect (TEmax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Drug Liking: Time to Maximum (Peak) Effect (TEmax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| High: Time to Maximum (Peak) Effect (TEmax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) |  | 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Sleepy: Time to Maximum (Peak) Effect (TEmax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Dizzy: Time to Maximum (Peak) Effect (TEmax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Nausea: Time to Maximum (Peak) Effect (TEmax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Feel Sick: Time to Maximum (Peak) Effect (TEmax) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min) |  | pre-dose, 5 min post-dose | 
| Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min) |  | pre-dose, 5 min post-dose | 
| Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min) |  | pre-dose, 5 min post-dose | 
| Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min) |  | pre-dose, 5 min post-dose | 
| Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min) |  | pre-dose, 5 min post-dose | 
| Plasma Decay Half-Life (t1/2) of Oxycodone | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Plasma Decay Half-Life (t1/2) of Oxymorphone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Plasma Decay Half-Life (t1/2) of Noroxycodone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Plasma Decay Half-Life (t1/2) of Naltrexone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Oxycodone Concentration-Time Curve (AUC0-1h) | AUC is a measure of the plasma concentration of the drug over time. | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Naltrexone Concentration-Time Curve (AUC0-1h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Oxycodone Concentration-Time Curve (AUC0-2h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Naltrexone Concentration-Time Curve (AUC0-2h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Oxycodone Concentration-Time Curve (AUC0-8h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Naltrexone Concentration-Time Curve (AUC0-8h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast) |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Systemic Clearance (Cl) of Oxycodone | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Systemic Clearance (Cl) of Oxymorphone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Systemic Clearance (Cl) of Noroxycodone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Systemic Clearance (Cl) of Naltrexone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Systemic Clearance (Cl) of 6-beta-naltrexol |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Volume of Distribution at Steady State (Vss) for Oxycodone | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Volume of Distribution at Steady State (Vss) for Oxymorphone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Volume of Distribution at Steady State (Vss) for Noroxycodone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Volume of Distribution at Steady State (Vss) for Naltrexone |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 
| Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol |  | pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abuse liability, drug liking, oxycodone, naltrexone, intravenous, pharmacodynamic, abuse potential