Clinical trial NCT02101840: Abuse Liability of Controlled-Release Oxycodone Formulations
Official title: Abuse Liability of Controlled-Release Oxycodone Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Substance-Related Disorders
Keywords: Substance-Related Disorders
Prescription Drug Misuse
Analgesics, Opioid
Oxycodone
Randomized Controlled Trial
Cross-Over Studies
Placebo
Healthy Volunteers
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2014-04-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Secondary outcomes:
measure: Pupil Diameter
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Cmax
timeFrame: Baseline to 6 hours post-administration
measure: Profile of Mood States (POMS)
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Psychomotor Performance
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Visual Analogue Scale for "Any Drug Effects"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Visual Analogue Scale for "Good Effects"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Visual Analogue Scale for "Bad Effects"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Visual Analogue Scale for "Feel Sick"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Visual Analogue Scale for "Nausea"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Visual Analogue Scale for "Sleepy"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Visual Analogue Scale for "Dizzy"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Sedation
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Euphoria
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Dysphoric Changes
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Psychotomimetic Changes
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Somatic Disturbances
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Sensory Disturbances
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Tmax
timeFrame: Baseline to 6 hours post drug administration
measure: Visual Analogue Scale for "Take Drug Again"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
measure: Likert Scale for "Sedation"
timeFrame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Beth Sproule, PharmD
role: PRINCIPAL_INVESTIGATOR
References: