Human Abuse PotentialPhase 1NCT05256108
Assessment of Abuse Potential of Cebranopadol in Humans
A Phase 1 study testing Oxycodone 40 mg, Tramadol 600 mg and Cebranopadol 600 µg in people with Human Abuse Potential, run by Tris Pharma, Inc. at 1 site in United States.
Trial summary
This study will be conducted to evaluate the abuse potential of single doses of cebranopadol as compared with oxycodone, tramadol and matching placebo in recreational drug users. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Abuse Potential
- What is being tested?
- Oxycodone 40 mg, Tramadol 600 mg and Cebranopadol 600 µg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 12 Jul 2022
- 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
- Willing and able to provide written informed consent
- Adult men or women aged 18 to 55 years, inclusive
- History of recreational opioid use defined as non therapeutic use at least 10 times in the subject's lifetime and at least once in the 12 weeks prior to the Enrollment Visit
- Body mass index between 19 kg/m2 and 32 kg/m2 inclusive, with a body weight of not less than 50 kg at Enrollment
- Subjects must be in good health as determined by medical history, physical examination, 12 lead electrocardiogram (ECG), and vital signs (pulse rate, systolic blood pressure and diastolic blood pressure, respiratory rate, and oxygen saturation using pulse oximetry) at Enrollment
Who cannot join
- Self-reported history of drug or alcohol dependence (lifetime) other than caffeine or nicotine as defined by DSM IV-TR criteria
- Current treatment or treatment within their lifetime for substance disorders, other than treatment for smoking cessation
- Positive or missing alcohol breath test at Enrollment; the alcohol breath test can be repeated and/or the subject rescheduled at the discretion of the investigator or designee
- Pregnant or breastfeeding or missing pregnancy test
- Unwillingness or inability to abstain from recreational drug use for the duration of the trial
- Current consumption of greater than 20 cigarettes per day or inability to abstain from smoking (or use of any nicotine-containing substance) for at least 8 hours
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- Participation in another clinical trial within 30 days prior to Enrollment that resulted in the administration of at least 1 dose of IMP
- Diseases or conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a history of cholecystectomy are not excluded
- Prolongation of QTcF (after repeated assessment) at Enrollment, i.e., >450 ms for men or >470 ms for women, or presence of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia), or use of concomitant medications that prolong the QT interval
- History of orthostatic hypotension or other cardiovascular diseases
- Any clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subject's safety during trial participation, e.g., significant pulmonary, gastrointestinal, cardiac, endocrine, metabolic, neurological, or psychiatric disorders
- Definite or suspected history of drug allergy or hypersensitivity to opioids or opioid antagonists
- Use of prescription medications within the longer of 14 days or 5 half-lives or use of over-the-counter medications within the longer of 7 days or 5 half-lives prior to dosing, exceptions may be made on a case-by-case basis (e.g., for medications with a short half-life or for topical medications) if approved by the medical monitor in agreement with the investigator
- Any contraindication for naloxone, oxycodone IR, or tramadol IR administration
- Not able to abstain from consumption of beverages or food containing caffeine (tea, coffee, cola, chocolate, etc.) or alcohol from 2 days prior to each Day 1 until discharge from the research unit; beverages or food containing quinine (e.g., bitter lemon, tonic water) from 1 week before Day 1 of the Qualification Phase until the final examination; grapefruit juice (sweet or sour) or Seville oranges from 1 week before Day 1 of the Qualification Phase until the final examination.
- Blood loss of 500 mL or more within 4 weeks before dosing in the treatment phase in this trial, including blood donation. Planned blood donations during the trial and up to 12 weeks after the Final Examination
- History of seizure disorder including unprovoked seizure and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy at the Enrollment Visit at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Randomized, Double-blind, Placebo- and Active-controlled Crossover Trial to Evaluate the Abuse Potential of Two Doses of Cebranopadol in Adult Nondependent Recreational Opioid Users
This study will be conducted to evaluate the abuse potential of single doses of cebranopadol as compared with oxycodone, tramadol and matching placebo in recreational drug users.
Read the detailed description
Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
- Conditions
- Human Abuse Potential
- Being tested
- Oxycodone 40 mg, Tramadol 600 mg, Placebo, Cebranopadol 600 µg, Cebranopadol 1000 µg
- Keywords
- pain, abuse, opioid
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 40 mgDrug
Also called Qualification Phase/ Treatment Phase
Participants will be administered a single dose of 6 capsules containing oxycodone and placebo in a randomized crossover manner
Tramadol 600 mgDrug
Also called Qualification Phase/ Treatment Phase
Participants will be administered a single dose of 6 capsules containing tramadol in a randomized crossover manner
PlaceboDrug
Also called Qualification Phase/ Treatment Phase
Participants will be administered a single dose of 6 capsules containing placebo in a randomized crossover manner
Cebranopadol 600 µgDrug
Also called Treatment Phase
Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner
Cebranopadol 1000 µgDrug
Also called Treatment Phase
Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner
| Study group | Role | What they receive |
|---|---|---|
| Cebranopadol 600 µg | Experimental | Single oral dose of 6 capsules containing 3 cebranopadol 200 µg tablets and placebo Receives: Drug: Cebranopadol 600 µg |
| Cebranopadol 1000 µg | Experimental | Single oral dose of 6 capsules containing 5 cebranopadol 200 µg tablets and placebo Receives: Drug: Cebranopadol 1000 µg |
| Oxycodone 40 mg | Active comparator | Single oral dose of 6 capsules containing 2 oxycodone 20 mg and placebo Receives: Drug: Oxycodone 40 mg |
| Tramadol 600 mg | Active comparator | Single oral dose of 6 capsules containing 6 tramadol 100 mg tablets Receives: Drug: Tramadol 600 mg |
| Placebo | Placebo comparator | Single oral dose of 6 capsules containing placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Liking Visual analog scale (VAS) Emax
The scale is a 0-100-point scale: 0 = "Strong disliking"; 50 = "Neither like nor dislike"; 100 = "Strong liking"
Measured: Treatment Phase: Intervals from predose to 48 hours post-dose
Secondary outcomes (4)
VAS rating for Overall Liking
The scale is a 0-100-point scale: 0 = "Strong Disliking", 50 = "Neither Like nor Dislike", 100 = "Strong Liking"
Measured: Treatment Phase: Intervals from predose to 48 hours post-dose
VAS rating for Take Drug Again
The scale is a 0-100-point scale: 0 = "Definitely would not"; 50 = "Do not care"; 100 = "Definitely would"
Measured: Treatment Phase: Intervals from predose to 48 hours post-dose
Pupillometry
Data from a series of frames will be used in the calculation, and the final display will show the weighted average and standard deviation of the pupil size. Measurements will be collected under mesopic lighting conditions
Measured: Treatment Phase: Intervals from predose to 48 hours post-dose
Multi-Tasking Test
Formerly known as the Attention Switching Task (AST), is a test of executive function which provides a measure of the ability to use multiple sources of potentially conflicting information to guide behavior.
Measured: Treatment Phase: Intervals from predose to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start28 Mar 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Abuse PotentialStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256108
- Sponsor's protocol ID
- PARK-101-HAP
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomized, Double-blind, Placebo- and Active-controlled Crossover Trial to Evaluate the Abuse Potential of Two Doses of Cebranopadol in Adult Nondependent Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT05256108
- Acronym / sponsor ID
- PARK-101-HAP
- Conditions
- Human Abuse Potential
- Keywords
- pain, abuse, opioid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 25 Feb 2022 (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.
This study will be conducted to evaluate the abuse potential of single doses of cebranopadol as compared with oxycodone, tramadol and matching placebo in recreational drug users.
Detailed description
Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
| Arm | Type | Receives |
|---|---|---|
| Cebranopadol 600 µg | Experimental | Drug: Cebranopadol 600 µgSingle oral dose of 6 capsules containing 3 cebranopadol 200 µg tablets and placebo |
| Cebranopadol 1000 µg | Experimental | Drug: Cebranopadol 1000 µgSingle oral dose of 6 capsules containing 5 cebranopadol 200 µg tablets and placebo |
| Oxycodone 40 mg | Active comparator | Drug: Oxycodone 40 mgSingle oral dose of 6 capsules containing 2 oxycodone 20 mg and placebo |
| Tramadol 600 mg | Active comparator | Drug: Tramadol 600 mgSingle oral dose of 6 capsules containing 6 tramadol 100 mg tablets |
| Placebo | Placebo comparator | Drug: PlaceboSingle oral dose of 6 capsules containing placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to provide written informed consent
- Adult men or women aged 18 to 55 years, inclusive
- History of recreational opioid use defined as non therapeutic use at least 10 times in the subject's lifetime and at least once in the 12 weeks prior to the Enrollment Visit
- Body mass index between 19 kg/m2 and 32 kg/m2 inclusive, with a body weight of not less than 50 kg at Enrollment
- Subjects must be in good health as determined by medical history, physical examination, 12 lead electrocardiogram (ECG), and vital signs (pulse rate, systolic blood pressure and diastolic blood pressure, respiratory rate, and oxygen saturation using pulse oximetry) at Enrollment
Key exclusion criteria (17 listed)
- Self-reported history of drug or alcohol dependence (lifetime) other than caffeine or nicotine as defined by DSM IV-TR criteria
- Current treatment or treatment within their lifetime for substance disorders, other than treatment for smoking cessation
- Positive or missing alcohol breath test at Enrollment; the alcohol breath test can be repeated and/or the subject rescheduled at the discretion of the investigator or designee
- Pregnant or breastfeeding or missing pregnancy test
- Unwillingness or inability to abstain from recreational drug use for the duration of the trial
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 40 mgAlso: Qualification Phase/ Treatment PhaseParticipants will be administered a single dose of 6 capsules containing oxycodone and placebo in a randomized crossover manner | Drug | Oxycodone 40 mg |
| Tramadol 600 mgAlso: Qualification Phase/ Treatment PhaseParticipants will be administered a single dose of 6 capsules containing tramadol in a randomized crossover manner | Drug | Tramadol 600 mg |
| PlaceboAlso: Qualification Phase/ Treatment PhaseParticipants will be administered a single dose of 6 capsules containing placebo in a randomized crossover manner | Drug | Placebo |
| Cebranopadol 600 µgAlso: Treatment PhaseParticipants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner | Drug | Cebranopadol 600 µg |
| Cebranopadol 1000 µgAlso: Treatment PhaseParticipants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner | Drug | Cebranopadol 1000 µg |
Primary outcome
Drug Liking Visual analog scale (VAS) Emax
Time frame: Treatment Phase: Intervals from predose to 48 hours post-dose
The scale is a 0-100-point scale: 0 = "Strong disliking"; 50 = "Neither like nor dislike"; 100 = "Strong liking"
4 secondary outcomes
VAS rating for Overall Liking
Time frame: Treatment Phase: Intervals from predose to 48 hours post-dose
VAS rating for Take Drug Again
Time frame: Treatment Phase: Intervals from predose to 48 hours post-dose
Pupillometry
Time frame: Treatment Phase: Intervals from predose to 48 hours post-dose
Multi-Tasking Test
Time frame: Treatment Phase: Intervals from predose to 48 hours post-dose
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 27 Jul 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 40 mg, Tramadol 600 mg and Cebranopadol 600 µg in people with Human Abuse Potential, run by Tris Pharma, Inc. at 1 site in United States.
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 5 inclusion and 17 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 27 Jul 2022. 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 United States. 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?
Drug Liking Visual analog scale (VAS) Emax (time frame: Treatment Phase: Intervals from predose to 48 hours post-dose). 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 27 Jul 2022.