Substance AbusePhase 1NCT03765346
A Comparison of How Likely it is That Different Tablets of Oxycodone Will be Broken up and Snorted by Adults Who Sometimes Take Drugs for Pleasure
A Phase 1 study testing Oxycodone IR ADF and Oxycodone API powder in people with Substance Abuse, run by Grünenthal GmbH at 1 site in Canada.
Trial summary
The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including 3 treatment periods), a Final Examination, and a Follow-up Phone Call. The Qualification Phase includes a naloxone challenge test (to verify that participants are not opioid-dependent) and a drug discrimination test (to… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Oxycodone IR ADF and Oxycodone API powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jul 2018to 5 Nov 2018
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants have given written informed consent to participate.
- Female or male participants, aged 18 years to 55 years inclusive at the time of the Enrollment Visit.
- Body mass index between 20 kilograms per square meter and 32 kilograms per square meter inclusive, with a minimum body weight of 55 kilograms.
- Participants must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant findings as determined by 12-lead electrocardiogram (ECG), vital signs (pulse rate, respiratory rate, systolic and diastolic blood pressure), oxygen saturation, body temperature, and safety laboratory parameters (hematology, clinical chemistry, clotting, and urinalysis).
- Female participants of childbearing potential must agree to use one of the acceptable contraceptive regimens listed below from at least 15 days prior to the first administration of IMP until at least 30 days after the last administration of IMP.
- For female participants of childbearing potential:
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- Combined (estrogen- and progestogen-containing) hormonal contraception.
- Progestogen-only hormonal contraception associated with inhibition of ovulation.
- An intra-uterine device (hormone-free).
- An intra-uterine hormone releasing system.
- Bilateral tubal occlusion.
- Double barrier methods (i.e., male condom in addition to diaphragm, spermicide, or contraceptive sponge).
- All female participants are considered to be of childbearing potential unless they have undergone hysterectomy or bilateral oophorectomy or have been postmenopausal for at least 12 months (i.e., spontaneous amenorrhea at least 1 year prior to screening and confirmed follicle-stimulating hormone [FSH] level above 40 international units per liter).
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes, i.e., for psychoactive effects, at least 10 times in their lifetime and at least once in the last 12 weeks before the Enrollment Visit.
- Participants who have intranasally insufflated drugs for recreational (non-therapeutic) purposes at least 3 times in the last 12 months before the Enrollment Visit.
Who cannot join
- Resting pulse rate below 50 beats per minute or above 100 beats per minute.
- Resting systolic blood pressure below 90 mmHg or above 140 mmHg. Resting diastolic blood pressure above 90 mmHg.
- Prolongation of the corrected QT interval (Fridericia), i.e., QTcF above 450 milliseconds, or presence of other of risk factors for torsade de pointes (e.g., heart failure, hypokalemia).
- Evidence for thyroid disease based on clinical and safety laboratory findings, including thyroid-stimulating hormone (TSH).
- Any laboratory value (from blood samples taken at the Enrollment Visit) meeting the following criteria:
- Out-of-reference range value for serum creatinine or clotting parameter prothrombin international normalized ratio.
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- Exclusion range met for urinalysis or alanine transaminase, aspartate transaminase, alkaline phosphatase, total bilirubin, glucose (fasted), gamma-glutamyl transferase, lactate dehydrogenase, potassium, total protein, sodium, calcium, hemoglobin, hematocrit, white blood cell count, or platelets.
- Out-of-reference range value for any other safety laboratory parameter that is judged by the investigator to be clinically relevant.
- Positive or missing virus serology test for human immunodeficiency virus Type 1 or Type 2 antibodies and antigen, hepatitis B surface antigen, hepatitis B core antigen antibodies, or hepatitis C virus antibodies.
- For female participants: positive or missing pregnancy test.
- Participant received an IMP or an investigational medical device in another clinical trial less than 30 days before the Enrollment Visit. Depending on the nature of the previous IMP or investigational medical device, a longer washout may be needed.
- Diseases or conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of orthostatic hypotension.
- Known history of or at risk of seizures (i.e., head trauma, epilepsy in family history, unclear loss of consciousness).
- Definite or suspected hypersensitivity to the active substance or to any of the excipients of the IMP; especially known hypersensitivity/intolerance or contraindications to opioids (including [history of] bronchial asthma, chronic obstructive pulmonary disease, pulmonary heart disease, diseases of the adrenal gland, paralytic ileus, prostatic hypertrophy, or urethral stricture), opioid antagonists, or any excipients of the drug formulation.
- Any hint of chronic drug abuse, e.g., injection site (not related to trial procedures).
- Unable to abstain from regular use of any medication (including prescription drugs, over-the-counter drugs, dietary supplements, and herbal remedies like St. John's Wort) from 2 weeks before the Enrollment Visit and anticipated use during the course of the trial. Exempt from this criterion are oral contraceptives in women of childbearing potential and topical medications without systemic effect (except those for intranasal use and nasal sprays).
- Lactating or breastfeeding women.
- Habitually smoking more than 20 cigarettes, 2 cigars, or 2 pipes of tobacco per day in the last 3 months before enrollment in this trial.
- Unable to refrain from smoking or unable to abstain from the use of prohibited nicotine-containing products (including electronic cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges) from 1 hour before until 5 hours after each IMP administration.
- Not willing or able to abstain from consumption of beverages or food containing quinine (bitter lemon, tonic water), grapefruit juice (sweet or sour), Seville oranges, or alcohol in the Qualification Phase and the Treatment Phase from 72 hours before the planned first administration of IMP in that phase until discharge from the trial site at the end of that phase.
- Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff.
- Not able to communicate meaningfully with the trial site staff.
- Employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, as well as family members of the employees or the investigator.
- Blood loss of 500 milliliters or more (e.g., owing to blood donation) less than 56 days before enrollment in this trial.
- Unable to establish reliable venous access.
- Substance or alcohol dependence (excluding nicotine and caffeine) in the last 12 months before enrollment in this trial, as defined by the diagnostic and statistical manual of mental disorders - fourth edition - text revision (DSM-IV-TR).
- Participant has ever participated in or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- Unwillingness or inability to abstain from recreational drug use for the duration of the trial.
- Serious psychiatric or neurological conditions.
- Nasal conditions, e.g., perforated nasal septum, irritated nasal mucosa, obstructed naris.
- History or current evidence of suicidal ideation or suicidal behavior, as assessed by the Columbia-suicide severity rating scale (C-SSRS) ("baseline/screening" version).
- Participation in another clinical trial with an IMP or investigational medical device since enrollment.
- Out-of-reference blood pressure or pulse rate if technical failure can be excluded and result is confirmed by at least 1 additional measurement: systolic blood pressure below 90 mmHg or above 140 mmHg, diastolic blood pressure above 90 mmHg, pulse rate below 50 beats/minute or above 100 beats/minute.
- Withdrawal of informed consent.
- Use of forbidden medication since enrollment in this trial, subject to individual decision by the investigator after consultation with the sponsor.
- Any relevant deterioration in the health of the participant since the Enrollment Visit possibly impacting participation in the trial, at the discretion of the investigator, including: adverse events; vital signs; physical examination, 12-lead ECG (relevant QTcF prolongation, i.e., QTcF above 450 milliseconds); other safety parameters.
- Blood loss of 100 milliliters or more since enrollment in this trial (excluding blood taken for this trial).
- For female participants: positive or missing pregnancy test.
- Positive or missing alcohol test or urine test for drugs of abuse (except for cannabinoids).
- Any hint, especially intravenous or intranasal, of chronic drug abuse, e.g., injection site (not related to trial procedures).
- Failure to comply with trial requirements (e.g., consumption of alcohol, beverages or food containing quinine, grapefruit juice, Seville oranges) judged by the investigator to affect participant safety or interfere with the integrity of the trial.
- Nasal conditions, e.g., perforated nasal septum, irritated nasal mucosa, obstructed naris.
- Current evidence of suicidal ideation or suicidal behavior, as assessed by the C-SSRS ("since last visit" version).
- Clinical opioid withdrawal scale (COWS) score greater than or equal to 5 after administration of naloxone on Day -1 of the Qualification Phase.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-site, Randomized, Double-blind, Double-dummy, Active-comparator, Placebo-controlled, 3-way Crossover Trial in Adult Non-dependent Recreational Opioid Users to Compare the Intranasal Abuse Potential of Immediate Release Abuse-deterrent and Standard Formulations of Oxycodone
The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including 3 treatment periods), a Final Examination, and a Follow-up Phone Call.
The Qualification Phase includes a naloxone challenge test (to verify that participants are not opioid-dependent) and a drug discrimination test (to determine whether or not participants are able to distinguish intranasally administered active drug from placebo). Participants will be randomized to receive a single intranasal dose each of oxycodone active pharmaceutical ingredient (API) and matching placebo in a double-blind manner. The total mass of each single dose will be 30 milligrams.
Participants who successfully complete the Qualification Phase are eligible to be included in the Treatment Phase. During the Treatment Phase, participants will receive test product, comparator, and placebo following a randomized, double-blind, double-dummy, 3-way crossover design. Participants will receive a single intranasal dose of each of the treatments (combined doses of investigational medicinal product {IMP}) on Day 1, Day 4, and Day 7 of the Treatment Phase. A single dose of a treatment is defined as insufflation of single doses of the 2 applicable IMPs in quick succession. The 2 applicable IMPs must be insufflated in the following pre-defined order. Oxycodone API or placebo to match oxycodone API must always be insufflated first. Oxycodone immediate release (IR) abuse-deterrent formulation (ADF) or placebo to match oxycodone IR ADF must always be insufflated second. The total mass of each single dose of treatment will be 570 milligrams.
- Conditions
- Substance Abuse
- Being tested
- Oxycodone IR ADF, Oxycodone API powder, Placebo to match oxycodone API powder, Placebo to match manipulated oxycodone IR ADF.
- Keywords
- intranasal abuse, abuse-deterrent
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone IR ADFDrug
Oxycodone IR ADF manipulated/crushed (mass of 540 mg, containing oxycodone hydrochloride 30 mg), in a standardized procedure.
Oxycodone API powderDrug
Oxycodone API powder (mass of 30 mg), containing oxycodone hydrochloride 30 mg.
Placebo to match oxycodone API powderDrug
Placebo to match oxycodone API powder (mass of 30 mg).
Placebo to match manipulated oxycodone IR ADF.Drug
Placebo to match oxycodone IR ADF, manipulated (mass of 540 mg).
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone IR ADF and placebo to match oxycodone API | Experimental | Participants receive a single intranasal dose of placebo to match oxycodone API powder (mass of 30 mg) followed by a single intranasal dose of manipulated oxycodone IR ADF (mass of 540 mg, containing oxycodone hydrochloride 30 mg). Receives: Drug: Oxycodone IR ADF; Drug: Placebo to match oxycodone API powder |
| Oxycodone API and placebo to match oxycodone IR ADF | Active comparator | Participants receive a single intranasal dose of oxycodone API powder (mass of 30 mg, containing oxycodone hydrochloride 30 mg) followed by a single intranasal dose of placebo to match manipulated oxycodone IR ADF (mass of 540 mg). Receives: Drug: Oxycodone API powder; Drug: Placebo to match manipulated oxycodone IR ADF. |
| Placebo to match oxycodone API and to match oxycodone IR ADF | Placebo comparator | Participants receive a single intranasal dose of placebo to match oxycodone API powder (mass of 30 mg) followed by a single intranasal dose of placebo to match manipulated oxycodone IR ADF (mass of 540 mg). Receives: Drug: Placebo to match oxycodone API powder; Drug: Placebo to match manipulated oxycodone IR ADF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak effect (Emax) for Drug Liking "at this moment".
100-point bipolar visual analog scale (VAS) ratings after each IMP administration in response to the statement "At this moment, my liking for this drug is". The 100 millimeter (mm) bipolar VAS is anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), to the left with "strong disliking" (score of 0 mm) and to the right with "strong liking" (score of 100 mm).
Measured: at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Secondary outcomes (14)
Maximum Plasma Concentration (Cmax) of oxycodone
The analysis in plasma will be performed by means of a validated LC-MS/MS method.
Measured: pre-dose and at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Area under the plasma concentration-time curve of oxycodone from time point 0 to t (AUC0-t)
The analysis in plasma will be performed by means of a validated LC-MS/MS method.
Measured: pre-dose and at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Area under the plasma concentration-time curve of oxycodone from time point 0 to infinity (AUC)
The analysis in plasma will be performed by means of a validated LC-MS/MS method.
Measured: pre-dose and at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
High: 100-point unipolar VAS
100-point unipolar VAS ratings after each IMP administration in response to the statement "At this moment, I am feeling high". The 100 mm unipolar VAS is anchored to the left with "not at all" (score of 0 mm) and to the right with "extremely" (score of 100).
Measured: at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Overall Drug Liking: 100-point bipolar VAS
100-point bipolar VAS ratings after each IMP administration in response to the statement "Overall, my liking for this drug is". The 100 mm bipolar VAS is anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), to the left with "strong disliking" (score of 0 mm) and to the right with "strong liking" (score of 100 mm).
Measured: at 12 and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Take Drug Again: 100-point bipolar VAS
100-point bipolar VAS ratings after each IMP administration in response to the statement "I would take this drug again". The 100 mm bipolar VAS is anchored in the center with a neutral anchor of "neutral" (score of 50 mm), to the left with "definitely not" (score of 0 mm) and to the right with "definitely so" (score of 100 mm).
Measured: at 12 and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Bad Effects: 100-point unipolar VAS
100-point unipolar VAS ratings after each IMP administration in response to the statement "At this moment, I can feel bad drug effects". The 100 mm unipolar VAS, is anchored to the left with "not at all" (score of 0 mm) and to the right with "extremely" (score of 100).
Measured: at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Ease Of Snorting: 100-point bipolar VAS
100-point bipolar VAS ratings after each IMP administration in response to the statement "How easy was it to snort?". The 100 mm bipolar VAS is anchored in the center with a neutral anchor of "neither easy nor difficult" (score of 50 mm), to the left with "very difficult" (score of 0 mm) and to the right with "very easy" (score of 100 mm).
Measured: at 0 hour as soon as possible after IMP administration on Day 1, Day 4, and Day 7
Pleasantness Of Snorting: 100-point bipolar VAS
100-point bipolar VAS ratings after each IMP administration in response to the statement "How does it feel in your nose?". The 100 mm bipolar VAS is anchored in the center with a neutral anchor of "neither pleasant nor unpleasant" (score of 50 mm), to the left with "very unpleasant" (score of 0 mm) and to the right with "very pleasant" (score of 100 mm).
Measured: at 0 hour as soon as possible after IMP administration on Day 1, Day 4, and Day 7
Pupillometry parameter: Apparent minimum post dose pupil diameter (PCmin)
The size of the participant's pupil will be measured (in mm) using a pupillometer. The same eye for each participant will be used for all measurements throughout the trial. Measurements will be collected under mesopic lighting conditions. PCmin will be calculated
Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Pupillometry parameter: Time to reach the apparent minimum diameter (PTmin)
The size of the participant's pupil will be measured (in mm) using a pupillometer. The same eye for each participant will be used for all measurements throughout the trial. Measurements will be collected under mesopic lighting conditions.
Measured: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Pupillometry parameter: The area over the curve to 1 hour relative to the baseline (PAOC0-1hour)
The size of the participant's pupil will be measured (in mm) using a pupillometer. The same eye for each participant will be used for all measurements throughout the trial. Measurements will be collected under mesopic lighting conditions.
Measured: Baseline up to 1 hour
Pupillometry parameter: The area over the curve to 8 hours relative to the baseline (PAOC0-8hours)
The size of the participant's pupil will be measured (in mm) using a pupillometer. The same eye for each participant will be used for all measurements throughout the trial. Measurements will be collected under mesopic lighting conditions.
Measured: Baseline up to 8 hours
Incidence of adverse events of manipulated IMP
Number of adverse events and number of participants with adverse events.
Measured: From the first IMP administration (Day 1) to the Final Examination (Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start24 Jul 2018
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765346
- Sponsor's protocol ID
- HP7030-03
- Other IDs
- U1111-1203-4920
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, Randomized, Double-blind, Double-dummy, Active-comparator, Placebo-controlled, 3-way Crossover Trial in Adult Non-dependent Recreational Opioid Users to Compare the Intranasal Abuse Potential of Immediate Release Abuse-deterrent and Standard Formulations of Oxycodone
- ClinicalTrials.gov ID
- NCT03765346
- Acronym / sponsor ID
- HP7030-03
- Conditions
- Substance Abuse
- Keywords
- intranasal abuse, abuse-deterrent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 5 Dec 2018 (actual)
- 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 trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including 3 treatment periods), a Final Examination, and a Follow-up Phone Call.
The Qualification Phase includes a naloxone challenge test (to verify that participants are not opioid-dependent) and a drug discrimination test (to determine whether or not participants are able to distinguish intranasally administered active drug from placebo). Participants will be randomized to receive a single intranasal dose each of oxycodone active pharmaceutical ingredient (API) and matching placebo in a double-blind manner. The total mass of each single dose will be 30 milligrams.
Participants who successfully complete the Qualification Phase are eligible to be included in the Treatment Phase. During the Treatment Phase, participants will receive test product, comparator, and placebo following a randomized, double-blind, double-dummy, 3-way crossover design. Participants will receive a single intranasal dose of each of the treatments (combined doses of investigational medicinal product {IMP}) on Day 1, Day 4, and Day 7 of the Treatment Phase. A single dose of a treatment is defined as insufflation of single doses of the 2 applicable IMPs in quick succession. The 2 applicable IMPs must be insufflated in the following pre-defined order. Oxycodone API or placebo to match oxycodone API must always be insufflated first. Oxycodone immediate release (IR) abuse-deterrent formulation (ADF) or placebo to match oxycodone IR ADF must always be insufflated second. The total mass of each single dose of treatment will be 570 milligrams.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxycodone IR ADF and placebo to match oxycodone API | Experimental | Drug: Oxycodone IR ADF, Drug: Placebo to match oxycodone API powderParticipants receive a single intranasal dose of placebo to match oxycodone API powder (mass of 30 mg) followed by a single intranasal dose of manipulated oxycodone IR ADF (mass of 540 mg, containing oxycodone hydrochloride 30 mg). |
| Oxycodone API and placebo to match oxycodone IR ADF | Active comparator | Drug: Oxycodone API powder, Drug: Placebo to match manipulated oxycodone IR ADF.Participants receive a single intranasal dose of oxycodone API powder (mass of 30 mg, containing oxycodone hydrochloride 30 mg) followed by a single intranasal dose of placebo to match manipulated oxycodone IR ADF (mass of 540 mg). |
| Placebo to match oxycodone API and to match oxycodone IR ADF | Placebo comparator | Drug: Placebo to match oxycodone API powder, Drug: Placebo to match manipulated oxycodone IR ADF.Participants receive a single intranasal dose of placebo to match oxycodone API powder (mass of 30 mg) followed by a single intranasal dose of placebo to match manipulated oxycodone IR ADF (mass of 540 mg). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Participants have given written informed consent to participate.
- Female or male participants, aged 18 years to 55 years inclusive at the time of the Enrollment Visit.
- Body mass index between 20 kilograms per square meter and 32 kilograms per square meter inclusive, with a minimum body weight of 55 kilograms.
- Participants must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant findings as determined by 12-lead electrocardiogram (ECG), vital signs (pulse rate, respiratory rate, systolic and diastolic blood pressure), oxygen saturation, body temperature, and safety laboratory parameters (hematology, clinical chemistry, clotting, and urinalysis).
- Female participants of childbearing potential must agree to use one of the acceptable contraceptive regimens listed below from at least 15 days prior to the first administration of IMP until at least 30 days after the last administration of IMP.
Key exclusion criteria (45 listed)
- Resting pulse rate below 50 beats per minute or above 100 beats per minute.
- Resting systolic blood pressure below 90 mmHg or above 140 mmHg. Resting diastolic blood pressure above 90 mmHg.
- Prolongation of the corrected QT interval (Fridericia), i.e., QTcF above 450 milliseconds, or presence of other of risk factors for torsade de pointes (e.g., heart failure, hypokalemia).
- Evidence for thyroid disease based on clinical and safety laboratory findings, including thyroid-stimulating hormone (TSH).
- Any laboratory value (from blood samples taken at the Enrollment Visit) meeting the following criteria:
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 |
|---|---|---|
| Oxycodone IR ADFOxycodone IR ADF manipulated/crushed (mass of 540 mg, containing oxycodone hydrochloride 30 mg), in a standardized procedure. | Drug | Oxycodone IR ADF and placebo to match oxycodone API |
| Oxycodone API powderOxycodone API powder (mass of 30 mg), containing oxycodone hydrochloride 30 mg. | Drug | Oxycodone API and placebo to match oxycodone IR ADF |
| Placebo to match oxycodone API powderPlacebo to match oxycodone API powder (mass of 30 mg). | Drug | Oxycodone IR ADF and placebo to match oxycodone API, Placebo to match oxycodone API and to match oxycodone IR ADF |
| Placebo to match manipulated oxycodone IR ADF.Placebo to match oxycodone IR ADF, manipulated (mass of 540 mg). | Drug | Oxycodone API and placebo to match oxycodone IR ADF, Placebo to match oxycodone API and to match oxycodone IR ADF |
Primary outcome
Peak effect (Emax) for Drug Liking "at this moment".
Time frame: at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
100-point bipolar visual analog scale (VAS) ratings after each IMP administration in response to the statement "At this moment, my liking for this drug is". The 100 millimeter (mm) bipolar VAS is anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), to the left with "strong disliking" (score of 0 mm) and to the right with "strong liking" (score of 100 mm).
14 secondary outcomes
Maximum Plasma Concentration (Cmax) of oxycodone
Time frame: pre-dose and at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Area under the plasma concentration-time curve of oxycodone from time point 0 to t (AUC0-t)
Time frame: pre-dose and at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Area under the plasma concentration-time curve of oxycodone from time point 0 to infinity (AUC)
Time frame: pre-dose and at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
High: 100-point unipolar VAS
Time frame: at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Overall Drug Liking: 100-point bipolar VAS
Time frame: at 12 and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Take Drug Again: 100-point bipolar VAS
Time frame: at 12 and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Bad Effects: 100-point unipolar VAS
Time frame: at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Ease Of Snorting: 100-point bipolar VAS
Time frame: at 0 hour as soon as possible after IMP administration on Day 1, Day 4, and Day 7
Pleasantness Of Snorting: 100-point bipolar VAS
Time frame: at 0 hour as soon as possible after IMP administration on Day 1, Day 4, and Day 7
Pupillometry parameter: Apparent minimum post dose pupil diameter (PCmin)
Time frame: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Pupillometry parameter: Time to reach the apparent minimum diameter (PTmin)
Time frame: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8
Pupillometry parameter: The area over the curve to 1 hour relative to the baseline (PAOC0-1hour)
Time frame: Baseline up to 1 hour
Pupillometry parameter: The area over the curve to 8 hours relative to the baseline (PAOC0-8hours)
Time frame: Baseline up to 8 hours
Incidence of adverse events of manipulated IMP
Time frame: From the first IMP administration (Day 1) to the Final Examination (Day 9)
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 5 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Grünenthal Study Director study director
Grünenthal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxycodone IR ADF and Oxycodone API powder in people with Substance Abuse, run by Grünenthal GmbH 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 15 inclusion and 45 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 5 Dec 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Peak effect (Emax) for Drug Liking "at this moment". (time frame: at 0.16, 0.33, 0.5, 0.75, 1, 1.33, 1.66, 2, 3, 4, 6, 8, 10, 12 hours, and 24 hours post-dose on Day 1 to 2; Day 4 to 5; and Day 7 to 8). 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 5 Dec 2018.