Abuse Liability of Controlled-Release Oxycodone Formulations

NCT02101840 | Completed Phase 4

• 1 other identifier: 043-2013
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Substance-Related Disorders; Prescription Drug Misuse; Analgesics, Opioid; Oxycodone; Randomized Controlled Trial; Cross-Over Studies; Placebo; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• 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

  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

  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

Study Arms (3)

Apo-Oxycodone CR®

ACTIVE COMPARATOR

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

Drug: Apo-Oxycodone CR®

OxyNEO®

ACTIVE COMPARATOR

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

Drug: OxyNEO®

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Apo-Oxycodone CR® DRUG

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

Also known as: Oxycodone

Apo-Oxycodone CR®

OxyNEO® DRUG

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

Also known as: Oxycodone

OxyNEO®

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University of Toronto: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related 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.

MeSH Terms

Conditions

Substance-Related Disorders; Prescription Drug Misuse

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Drug Misuse

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Beth Sproule, PharmD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 2, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

CA (1)