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A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted

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

Condition(s) targeted: Healthy

Intervention: ALO-02 weight-matched placebo (Drug); crushed ALO-02 30 mg/3.6 mg (Drug); oxycodone weight-matched placebo (Drug); crushed oxycodone IR 30 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 when they are crushed and snorted.

Clinical Details

Official title: A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Single-Dose, 4-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 Intranasally 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:

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

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

High: Peak Effect (Emax)

Drug Liking: 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

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

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

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

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

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

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

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

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

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

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

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

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

Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for "burning"

Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "burning"

Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "burning"

Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "burning"

Percentage of dose (drug powder) insufflated

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

Maximum Observed Plasma Concentration (Cmax) of Oxycodone

Maximum Observed Plasma Concentration (Cmax) of Oxymorphone

Maximum Observed Plasma Concentration (Cmax) of Noroxycodone

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 Oxycodone

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

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)

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 and at least once in the 8 weeks before Visit 1 (Screening Visit).

- Must have experience with intranasal opioid administration (snorted opioid drugs on

at least 3 occassions within the last year before Visit 1 (Screening Visit). 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.

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 11, 2013

Page last updated: August 23, 2015

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