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.
Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Participants will be administered a single dose of 6 capsules containing oxycodone and placebo in a randomized crossover manner
Participants will be administered a single dose of 6 capsules containing tramadol in a randomized crossover manner
Participants will be administered a single dose of 6 capsules containing placebo in a randomized crossover manner
Ohio Clinical Trials
Columbus, Ohio, United States
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"
Time frame: Treatment Phase: Intervals from predose to 48 hours post-dose
VAS rating for Overall Liking
The scale is a 0-100-point scale: 0 = "Strong Disliking", 50 = "Neither Like nor Dislike", 100 = "Strong Liking"
Time frame: 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"
Time frame: 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
Time frame: 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.
Time frame: Treatment Phase: Intervals from predose to 48 hours post-dose
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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