Abuse Liability of Controlled-Release Oxycodone Formulations

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Drug: Apo-Oxycodone CR®; Drug: OxyNEO®; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2S1
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Apo-Oxycodone CR®; a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®	Drug: Apo-Oxycodone CR®; a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®; Other Names: Oxycodone
Active Comparator: OxyNEO®; a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®	Drug: OxyNEO®; a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®; Other Names: Oxycodone
Placebo Comparator: Placebo; a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products	Drug: Placebo; a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupil Diameter		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Cmax	Plasma oxycodone concentration	Baseline to 6 hours post-administration
Profile of Mood States (POMS)		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Psychomotor Performance	Digit Symbol Substitution Test (DSST)	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Any Drug Effects"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Good Effects"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Bad Effects"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Feel Sick"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Nausea"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Sleepy"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Dizzy"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Sedation	Addiction Research Center Inventory (ARCI)	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Euphoria	Addiction Research Center Inventory (ARCI)	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Dysphoric Changes	Addiction Research Center Inventory (ARCI)	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Psychotomimetic Changes	Addiction Research Center Inventory (ARCI)	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Somatic Disturbances	Addiction Research Center Inventory (ARCI)	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Sensory Disturbances	Addiction Research Center Inventory (ARCI)	Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Tmax	Plasma oxycodone concentrations	Baseline to 6 hours post drug administration
Visual Analogue Scale for "Take Drug Again"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Likert Scale for "Sedation"		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: University of Toronto

Publications and helpful links

Helpful Links

• The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 30, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Randomized Controlled Trial; Substance-Related Disorders; Placebo; Analgesics, Opioid; Oxycodone; Cross-Over Studies; Prescription Drug Misuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: 043-2013