Abuse Liability of Controlled-Release Oxycodone Formulations

Substance-Related Disorders Clinical Trial

Official title:

Abuse Liability of Controlled-Release Oxycodone Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101840
• Other study ID #: 043-2013
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2014
• Last updated: January 8, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Drug:
• Apo-Oxycodone CR®
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®
• Placebo
a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Pupil Diameter		Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration	No
Secondary	Cmax	Plasma oxycodone concentration	Baseline to 6 hours post-administration	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Tmax	Plasma oxycodone concentrations	Baseline to 6 hours post drug administration	No
Secondary	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	No
Secondary	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	No

External 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.