NCT02101840

Abuse Liability of Controlled-Release Oxycodone Formulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to examine the abuse liability of a single 40mg dose of 2 controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent recreational opioid users by assessing the self-reported acute effects of the drugs and taking blood samples to measure drug concentrations. The investigators think there may be differences in how well these drugs are liked when swallowed whole due to differences in how the products are formulated.

Detailed description

This is a single-center, single-dose, double-blind, placebo-controlled, randomized, crossover, abuse liability study conducted in healthy subjects who are non-dependent recreational opioid users. The study consists of 3 study days during which each subject will take one tablet of either 40mg OxyNEO®, 40mg Apo-Oxycodone CR®, or placebo. The participants will be assessed for both pharmacokinetic and pharmacodynamic outcomes.

Conditions

• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	Apo-Oxycodone CR®	a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®
DRUG	OxyNEO®	a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®
DRUG	Placebo	a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-04-02
• Last updated: 2015-01-09

Locations

1 site across 1 country: Canada