Abuse Liability of Controlled-Release Oxycodone Formulations

Condition(s) targeted: Substance-Related Disorders

Intervention: Apo-Oxycodone CR® (Drug); OxyNEO® (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Centre for Addiction and Mental Health

Official(s) and/or principal investigator(s):
Beth Sproule, PharmD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health

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.

Official title: Abuse Liability of Controlled-Release Oxycodone Formulations

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome:

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

Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration

Secondary outcome:

Pupil Diameter

Cmax

Profile of Mood States (POMS)

Psychomotor Performance

Visual Analogue Scale for "Any Drug Effects"

Visual Analogue Scale for "Good Effects"

Visual Analogue Scale for "Bad Effects"

Visual Analogue Scale for "Feel Sick"

Visual Analogue Scale for "Nausea"

Visual Analogue Scale for "Sleepy"

Visual Analogue Scale for "Dizzy"

Sedation

Euphoria

Dysphoric Changes

Psychotomimetic Changes

Somatic Disturbances

Sensory Disturbances

Tmax

Visual Analogue Scale for "Take Drug Again"

Likert Scale for "Sedation"

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.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

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

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.

Starting date: February 2014
Last updated: January 8, 2015