Abuse Liability of Controlled-Release Oxycodone Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apo-Oxycodone CR®

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

Group Type ACTIVE_COMPARATOR

Apo-Oxycodone CR®

Intervention Type DRUG

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®

Group Type ACTIVE_COMPARATOR

OxyNEO®

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Apo-Oxycodone CR®

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

Intervention Type DRUG

OxyNEO®

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Oxycodone Oxycodone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes