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

Brief summary (from the registry)

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.

Study details

Official title

A Randomized, Double-blind, 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.

Conditions

• Healthy

Interventions

• Drug: 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

Sponsor

Pfizer

Collaborators

Syneos Health

Start date

2013-02

Primary completion

2013-07

Sex

All

Age range

from 18 Years to 55 Years

Healthy volunteers

true

Results posted

Yes, on ClinicalTrials.gov

Countries

Canada

Total sites listed

1

Eligibility criteria

Canadian sites (1)