Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
72
During the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
Part 1 Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
Part 1 Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
Vince and Associates Clinical Research Inc
Overland Park, Kansas, United States
Maximum effect (Emax) for "At this Moment" Drug Liking visual analog scale (VAS).
The drug liking VAS measures the participant's liking for the drug and is scored from 0 to 100, with 0 reflecting "Strong disliking" and 100 reflecting "Strong liking".
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Maximum effect (Emax)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Minimum effect (Emin)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time to Emax (TEmax)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time to Emin (TEmin)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Time averaged area under the effect curve (TA_AUE)
Time frame: Treatment Phase: Hour 0 and up to 24 Hours post-dose
Maximum plasma drug concentration (Cmax)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Treatment Phase: Pre-dose and up to 24 hours post-dose
Adverse events
Time frame: Part 1: 6 weeks, Part 2: 9 weeks
Proportion of abnormal electrocardiograms
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Part 1: 6 weeks, Part 2: 9 weeks
Columbia-Suicide Severity Rating Scale
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (least severe) to 5 (most severe).
Time frame: Part 1: 6 weeks, Part 2: 9 weeks