The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. This randomized, placebo-controlled, double-blind study is designed as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001 during a THC challenge. Results of this study will inform the future potential use of ANEB-001 as an emergency treatment for acute cannabinoid intoxication.
This study will evaluate whether ANEB-001 effectively inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC). All cohorts in part A and B of the study will be randomized, double-blind and placebo-controlled. Randomization is deemed appropriate to avoid selection bias for active compound or placebo treatment. A double-blind and placebo-controlled design is deemed appropriate because of the safety, tolerability and pharmacodynamic assessments that will be performed in this study. By double-blinding the study, bias arising from study subject's or investigator's knowledge about treatment assignment is avoided. Part C does not include a placebo group and will therefore not be blinded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
154
Centre for Human Drug Research (CHDR)
Leiden, South Holland, Netherlands
Subjective Feeling High
Feeling High on a visual analog scale (mm)
Time frame: Day 1
Postural stability
Body sway (mm);
Time frame: Day 1
Subjective Alertness
Alertness on a visual analog scale (mm)
Time frame: Day 1
Heart Rate
Heart Rate in beats/min
Time frame: Day 1
Subjective Mood
Mood on a visual analog scale (mm)
Time frame: Day 1
Subjective Calmness
Calmness on a visual analog scale (mm)
Time frame: Day 1
Feeling of Drug Effect
Feeling of drug effect on a visual analog scale (mm)
Time frame: Day 1
Symbol Digit Substitution Test (SDST)
Part C Only
Time frame: Day 1
Visual Verbal Learning Test (VVLT)
Part C Only
Time frame: Day 1
Timed Up-and-Go test (TUG)
Part C Only
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Time frame: Day 1
Alternate Finger Tapping (AFT)
Part C Only
Time frame: Day 1
Basic Symptom Inventory (BSI)
Part C Only
Time frame: Day 1
Brief Psychiatric Rating Scale (BPRS)
Part C Only
Time frame: Day 1
Clinical Global Impression of Severity (CGIS)
Part C Only
Time frame: Day 1