An Early Phase 1 interventional study of Naloxone and Delta-9-THC in Healthy, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by Yale University · Early Phase 1, Interventional, and Basic science
The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.
Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: Naloxone · Drug: Placebo
Drug: Delta-9-THC · Drug: Placebo
Drug: Naloxone · Drug: Delta-9-THC
Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push
Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.
Placebo
Behavioral Measures
Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).
Time frame: 4 test days
Visual analog scales
Will assess subjective effects, perceptual alterations, and cognitive effects.
Time frame: 4 test days
Clinician Administered Dissociative States Scales (CADSS)
Will measure subjective effects, perceptual alterations, and cognitive effects.
Time frame: 4 test days
Psychotomimetic States Inventory (PSI)
Will assess subjective effects, perceptual alterations, and cognitive effects.
Time frame: 4 test days
Marijuana Withdrawal Scale
Will assess subjective effects, perceptual alterations, and cognitive effects.
Time frame: 4 test days
Clinical Opiate Withdrawal Scale
Will assess subjective effects, perceptual alterations, and cognitive effects.
Time frame: 4 test days
Marijuana Craving Scale
Will assess subjective effects, perceptual alterations, and cognitive effects.
Time frame: 4 test days
Neuro cognitive battery
Will assess cognitive effects.
Time frame: 4 test days
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Yale University