Substance-Related DisordersPhase 4NCT02101840
Abuse Liability of Controlled-Release Oxycodone Formulations
A Phase 4 study testing Apo-Oxycodone CR® and OxyNEO® in people with Substance-Related Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Apo-Oxycodone CR® and OxyNEO®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Apo-Oxycodone CR®, OxyNEO®, Placebo
- Keywords
- Substance-Related Disorders, Prescription Drug Misuse, Analgesics, Opioid, Oxycodone, Randomized Controlled Trial, Cross-Over Studies, Placebo, Healthy Volunteers
- Medical subject headings
- Substance-Related Disorders, Prescription Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apo-Oxycodone CR®Drug
Also called Oxycodone
a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®
OxyNEO®Drug
Also called Oxycodone
a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®
PlaceboDrug
a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products
| Study group | Role | What they receive |
|---|---|---|
| Apo-Oxycodone CR® | Active comparator | a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR® Receives: Drug: Apo-Oxycodone CR® |
| OxyNEO® | Active comparator | a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO® Receives: Drug: OxyNEO® |
| Placebo | Placebo comparator | a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Secondary outcomes (20)
Pupil Diameter
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Cmax
Plasma oxycodone concentration
Measured: Baseline to 6 hours post-administration
Profile of Mood States (POMS)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Psychomotor Performance
Digit Symbol Substitution Test (DSST)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Any Drug Effects"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Good Effects"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Bad Effects"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Feel Sick"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Nausea"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Sleepy"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Visual Analogue Scale for "Dizzy"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Sedation
Addiction Research Center Inventory (ARCI)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Euphoria
Addiction Research Center Inventory (ARCI)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Dysphoric Changes
Addiction Research Center Inventory (ARCI)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Psychotomimetic Changes
Addiction Research Center Inventory (ARCI)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Somatic Disturbances
Addiction Research Center Inventory (ARCI)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Sensory Disturbances
Addiction Research Center Inventory (ARCI)
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Tmax
Plasma oxycodone concentrations
Measured: Baseline to 6 hours post drug administration
Visual Analogue Scale for "Take Drug Again"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Likert Scale for "Sedation"
Measured: Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Beth Sproule, Centre for Addiction and Mental Health
- Investigators
- Beth Sproule, PharmD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101840
- Sponsor's protocol ID
- 043-2013
- Status last verified
- Jan 2015
- First submitted
- 24 Mar 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abuse Liability of Controlled-Release Oxycodone Formulations
- ClinicalTrials.gov ID
- NCT02101840
- Acronym / sponsor ID
- 043-2013
- Conditions
- Substance-Related Disorders
- Keywords
- Substance-Related Disorders, Prescription Drug Misuse, Analgesics, Opioid, Oxycodone, Randomized Controlled Trial, Cross-Over Studies, Placebo, Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apo-Oxycodone CR® | Active comparator | Drug: Apo-Oxycodone CR®a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR® |
| OxyNEO® | Active comparator | Drug: OxyNEO®a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO® |
| Placebo | Placebo comparator | Drug: Placeboa single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apo-Oxycodone CR®Also: Oxycodonea single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR® | Drug | Apo-Oxycodone CR® |
| OxyNEO®Also: Oxycodonea single 40mg oral dose of the controlled release oxycodone formulation OxyNEO® | Drug | OxyNEO® |
| Placeboa single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products | Drug | Placebo |
Primary outcome
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
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
20 secondary outcomes
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
Cmax
Time frame: Baseline to 6 hours post-administration
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Tmax
Time frame: Baseline to 6 hours post drug administration
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Sproule, PharmD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apo-Oxycodone CR® and OxyNEO® in people with Substance-Related Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.