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Abuse Liability of Controlled-Release Oxycodone Formulations

NCT02101840 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-01-09

No results posted yet for this study

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.

Conditions

  • Substance-Related Disorders

Interventions

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

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Beth Sproule, PharmD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101840 on ClinicalTrials.gov