Human Abuse Potential
Conditions
Keywords
pain, abuse, opioid
Brief 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.
Detailed description
Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
Interventions
DRUGOxycodone 40 mg
Participants will be administered a single dose of 6 capsules containing oxycodone and placebo in a randomized crossover manner
DRUGTramadol 600 mg
Participants will be administered a single dose of 6 capsules containing tramadol in a randomized crossover manner
DRUGPlacebo
Participants will be administered a single dose of 6 capsules containing placebo in a randomized crossover manner
Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner
Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner
Sponsors
Tris Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
To ensure blinding to the treatment, subjects will receive 6 identically looking capsules that will contain one of the 5 assigned treatments. Subjects will be randomized 1:1:1:1:1 and will receive one of 2 cebranopadol doses: oxycodone IR: tramadol IR: placebo in each of the 5 treatment periods.
Intervention model description
Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Liking Visual analog scale (VAS) Emax | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS rating for Overall Liking | 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 |
| VAS rating for Take Drug Again | Treatment Phase: Intervals from predose to 48 hours post-dose | The scale is a 0-100-point scale: 0 = Definitely would not; 50 = Do not care; 100 = Definitely would |
| Pupillometry | Treatment Phase: Intervals from predose to 48 hours post-dose | 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 |
| Multi-Tasking Test | Treatment Phase: Intervals from predose to 48 hours post-dose | 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. |
Countries
United States
Outcome results
None listed