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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Placebo (Drug); Oxycodone + Naltrexone (Drug); Oxycodone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome:

Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours

Drug Liking: Peak Effect (Emax)

High: Area Under Effect Curve (AUE) From 0-2 Hours

High: Peak Effect (Emax)

Secondary outcome:

Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour

Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours

High: Area Under Effect Curve (AUE) From 0-1 Hour

High: Area Under Effect Curve (AUE) From 0-8 Hours

Take Drug Again: Peak Effect (Emax)

Take Drug Again: Mean Effect (Emean)

Overall Drug Liking: Peak Effect (Emax)

Overall Drug Liking: Mean Effect (Emean)

Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour

Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours

Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours

Nausea: Area Under Effect Curve (AUE) From 0-1 Hour

Nausea: Area Under Effect Curve (AUE) From 0-2 Hours

Nausea: Area Under Effect Curve (AUE) From 0-8 Hours

Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour

Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours

Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours

Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour

Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours

Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours

Any Drug Effects: Peak Effect (Emax)

Good Drug Effects: Peak Effect (Emax)

Bad Drug Effects: Peak Effect (Emax)

Feel Sick: Peak Effect (Emax)

Nausea: Peak Effect (Emax)

Sleepy: Peak Effect (Emax)

Dizzy: Peak Effect (Emax)

Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour

Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours

Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours

Pupillometry: Peak Effect (Emax)

Pupillometry: Time to Maximum (Peak) Effect (TEmax)

Drug Liking: Time to Maximum (Peak) Effect (TEmax)

High: Time to Maximum (Peak) Effect (TEmax)

Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Sleepy: Time to Maximum (Peak) Effect (TEmax)

Dizzy: Time to Maximum (Peak) Effect (TEmax)

Nausea: Time to Maximum (Peak) Effect (TEmax)

Feel Sick: Time to Maximum (Peak) Effect (TEmax)

Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)

Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)

Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)

Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)

Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)

Plasma Decay Half-Life (t1/2) of Oxycodone

Plasma Decay Half-Life (t1/2) of Oxymorphone

Plasma Decay Half-Life (t1/2) of Noroxycodone

Plasma Decay Half-Life (t1/2) of Naltrexone

Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol

Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)

Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)

Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)

Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)

Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)

Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)

Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)

Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)

Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)

Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)

Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)

Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)

Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)

Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)

Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)

Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)

Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)

Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)

Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)

Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)

Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone

Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone

Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone

Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone

Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol

Systemic Clearance (Cl) of Oxycodone

Systemic Clearance (Cl) of Oxymorphone

Systemic Clearance (Cl) of Noroxycodone

Systemic Clearance (Cl) of Naltrexone

Systemic Clearance (Cl) of 6-beta-naltrexol

Volume of Distribution at Steady State (Vss) for Oxycodone

Volume of Distribution at Steady State (Vss) for Oxymorphone

Volume of Distribution at Steady State (Vss) for Noroxycodone

Volume of Distribution at Steady State (Vss) for Naltrexone

Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Salt Lake City, Utah 84106, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2013
Last updated: October 7, 2013

Page last updated: August 23, 2015

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