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Substance-Related Disorders | Abuse Liability of Controlled-Release Oxycodone Formulations

Substance-Related Disorders research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Healthy male and female subjects 18 to 50 years of age - Willing and capable to give written informed consent - Subjects must have used opioids recreationally to achieve a \"high\" on at least five occasions in the 12 months before screening and at least once in the 90 days before screening according to self-report - Females of childbearing potential have to use a medically acceptable form of birth control and have a negative pregnancy test - Pass medical assessment, which includes physical examination, assessment of medical history, vital signs, blood work, and urine toxicology screen - Willing to abstain from alcohol 12 hours before and during the study days Exclusion Criteria: - Current or past Axis I psychiatric illness (including current drug dependence or past opioid dependence, except nicotine dependence) - Current hepatic disease or renal failure - Pregnancy or lactation in women - Current medication that is known to interact with opioids - Known contraindications or hypersensitivity to opioids - Current opioid therapy - Chronic pain disorder requiring regular medication

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Substance-Related Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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:Placeboa single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Apo-Oxycodone CR®a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®

OxyNEO®a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®

Placeboa single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products

Study Status

Completed

Start Date: February 2014

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration

Secondary Outcome: Pupil Diameter

Study sponsors, principal investigator, and references

Principal Investigator: Beth Sproule, PharmD

Lead Sponsor: Centre for Addiction and Mental Health

Collaborator: University of Toronto

More information:https://clinicaltrials.gov/show/NCT02101840

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