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Abuse Liability of Controlled-Release Oxycodone Formulations

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ClinicalTrials.gov Identifier: NCT02101840
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : January 9, 2015
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Beth Sproule, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Drug: Apo-Oxycodone CR® Drug: OxyNEO® Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Abuse Liability of Controlled-Release Oxycodone Formulations
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  2. Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration [ Time Frame: 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 :
  1. Pupil Diameter [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  2. Cmax [ Time Frame: Baseline to 6 hours post-administration ]
    Plasma oxycodone concentration

  3. Profile of Mood States (POMS) [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  4. Psychomotor Performance [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
    Digit Symbol Substitution Test (DSST)

  5. Visual Analogue Scale for "Any Drug Effects" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  6. Visual Analogue Scale for "Good Effects" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  7. Visual Analogue Scale for "Bad Effects" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  8. Visual Analogue Scale for "Feel Sick" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  9. Visual Analogue Scale for "Nausea" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  10. Visual Analogue Scale for "Sleepy" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  11. Visual Analogue Scale for "Dizzy" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  12. Sedation [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
    Addiction Research Center Inventory (ARCI)

  13. Euphoria [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
    Addiction Research Center Inventory (ARCI)

  14. Dysphoric Changes [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
    Addiction Research Center Inventory (ARCI)

  15. Psychotomimetic Changes [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
    Addiction Research Center Inventory (ARCI)

  16. Somatic Disturbances [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
    Addiction Research Center Inventory (ARCI)

  17. Sensory Disturbances [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
    Addiction Research Center Inventory (ARCI)

  18. Tmax [ Time Frame: Baseline to 6 hours post drug administration ]
    Plasma oxycodone concentrations

  19. Visual Analogue Scale for "Take Drug Again" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]
  20. Likert Scale for "Sedation" [ Time Frame: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101840


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
University of Toronto
Investigators
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Principal Investigator: Beth Sproule, PharmD Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: Beth Sproule, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02101840     History of Changes
Other Study ID Numbers: 043-2013
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Beth Sproule, Centre for Addiction and Mental Health:
Substance-Related Disorders
Prescription Drug Misuse
Analgesics, Opioid
Oxycodone
Randomized Controlled Trial
Cross-Over Studies
Placebo
Healthy Volunteers

Additional relevant MeSH terms:
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Oxycodone
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents