Trial record 3 of 518 for:    Open Studies | "Substance-Related Disorders"

Abuse Liability of Controlled-Release Oxycodone Formulations

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre for Addiction and Mental Health
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Beth Sproule, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT02101840
First received: March 24, 2014
Last updated: June 22, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Substance-Related Disorders
Drug: Apo-Oxycodone CR®
Drug: OxyNEO®
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Abuse Liability of Controlled-Release Oxycodone Formulations

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: Baseline to 6 hours post-administration ] [ Designated as safety issue: No ]
    Plasma oxycodone concentration

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Digit Symbol Substitution Test (DSST)

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Addiction Research Center Inventory (ARCI)

  • 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 ] [ Designated as safety issue: No ]
    Addiction Research Center Inventory (ARCI)

  • 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 ] [ Designated as safety issue: No ]
    Addiction Research Center Inventory (ARCI)

  • 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 ] [ Designated as safety issue: No ]
    Addiction Research Center Inventory (ARCI)

  • 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 ] [ Designated as safety issue: No ]
    Addiction Research Center Inventory (ARCI)

  • 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 ] [ Designated as safety issue: No ]
    Addiction Research Center Inventory (ARCI)

  • Tmax [ Time Frame: Baseline to 6 hours post drug administration ] [ Designated as safety issue: No ]
    Plasma oxycodone concentrations

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101840

Contacts
Contact: Beth Sproule, PharmD 416-535-8501 ext 36501 beth.sproule@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Principal Investigator: Beth Sproule, PharmD         
Sub-Investigator: Andrew Smith, MDCM         
Sub-Investigator: Keyghobad Farid Araki, MD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
University of Toronto
Investigators
Principal Investigator: Beth Sproule, PharmD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

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
Study First Received: March 24, 2014
Last Updated: June 22, 2014
Health Authority: Canada: Health Canada

Keywords provided by 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:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014