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A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

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); intact ALO-02 60 mg/7.2 mg (Drug); crushed ALO-02 60 mg/7.2 mg (Drug); crushed oxycodone IR 60 mg (Drug); crushed ALO-02 40 mg/4.8 mg (Drug); crushed oxycodone IR 40 mg (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 determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Clinical Details

Official title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-Dose, 6-Way Crossover Study to Determine the Relative Abuse Potential of ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules) Compared to Oxycodone Immediate Release and Placebo When Administered Orally to Non-Dependent, Recreational Opioid Users

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

Primary outcome:

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

High: Peak Effect (Emax)

Drug Liking: Peak Effect (Emax)

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

Secondary outcome:

Maximum Observed Plasma Concentration (Cmax) of oxymorphone

Maximum Observed Plasma Concentration (Cmax) of noroxycodone

Bad Drug Effects: Peak Effect (Emax)

Nausea: Peak Effect (Emax)

Feel Sick: Peak Effect (Emax)

Sleepy: Peak Effect (Emax)

Dizzy: Peak Effect (Emax)

Pupillometry: Peak Effect (Emax)

Good Drug Effects: Peak Effect (Emax)

Any Drug Effects: Peak Effect (Emax)

Maximum Observed Plasma Concentration (Cmax) of oxycodone

Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone

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

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for oxycodone

Area under the Concentration-Time Curve (AUC0-1h) for oxycodone

Area under the Concentration-Time Curve (AUC0-2h) for oxycodone

Area under the Concentration-Time Curve (AUC0-8h) for oxycodone

Area under the Concentration-Time Curve (AUC0-12h) for oxycodone

Area under the Concentration-Time Curve (AUC0-24h) for oxycodone

Plasma Decay Half-Life (t1/2) for oxycodone

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

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

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

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

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

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

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

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

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

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

Take Drug Again: Peak Effect (Emax)

Take Drug Again: Mean Effect (Emean)

Take Drug Again: Minimum Effect (Emin)

Overall Drug Liking: Peak Effect (Emax)

Overall Drug Liking: Minimum Effect (Emin)

Overall Drug Liking: Mean Effect (Emean)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours

Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours

Drug Liking: Area Under Effect Curve (AUE) From 0-36 Hours

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

High: Area Under Effect Curve (AUE) From 0-12 Hours

High: Area Under Effect Curve (AUE) From 0-24 Hours

High: Area Under Effect Curve (AUE) From 0-36 Hours

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

Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours

Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours

Any Effects: Area Under Effect Curve (AUE) From 0-36 Hours

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

Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours

Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours

Good Effects: Area Under Effect Curve (AUE) From 0-36 Hours

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

Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours

Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours

Bad Effects: Area Under Effect Curve (AUE) From 0-36 Hours

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

Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours

Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours

Feel Sick: Area Under Effect Curve (AUE) From 0-36 Hours

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

Nausea: Area Under Effect Curve (AUE) From 0-12 Hours

Nausea: Area Under Effect Curve (AUE) From 0-24 Hours

Nausea: Area Under Effect Curve (AUE) From 0-36 Hours

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

Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours

Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours

Sleepy: Area Under Effect Curve (AUE) From 0-36 Hours

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

Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours

Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours

Dizzy: Area Under Effect Curve (AUE) From 0-36 Hours

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

Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours

Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours

Pupillometry: Area Under Effect Curve (AUE) From 0-36 Hours

Maximum Observed Plasma Concentration (Cmax) of naltrexone

Maximum Observed Plasma Concentration (Cmax) of 6-beta-naltrexol

Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxymorphone

Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone

Time to Reach Maximum Observed Plasma Concentration (Tmax) of naltrexone

Time to Reach Maximum Observed Plasma Concentration (Tmax) of 6-beta-naltrexol

Detailed description: Abuse Liability Study

Eligibility

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

Criteria:

Inclusion Criteria:

- Healthy subjects.

- Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic

purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit. Exclusion Criteria:

- Diagnosis of substance and/or alcohol dependence.

- Subject has participated in, is currently participating in, or is seeking treatment

for substance and/or alcohol related disorder.

- History of sleep apnea.

- Positive urine drug screen (UDS) for other that marijuana.

- Positive for Hepatitis B or C and HIV on Screening.

Locations and Contacts

Pfizer Investigational Site, Toronto, Ontario M5V 2T3, Canada
Additional Information

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

Starting date: February 2013
Last updated: September 25, 2013

Page last updated: August 23, 2015

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