The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG and then assessing their responses to THC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
38
Active Delta-9-THC (0.036 mg/kg) given intravenously.
A dose given sublingually.
A placebo dose given sublingually.
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS.
Time frame: Baseline, +110, +180, and +240 minutes after start of THC Infusion
Clinician Administered Dissociative Symptoms Scale (CADSS)
Perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-reported items and 9 clinician-rated items. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.
Time frame: Baseline; +15, +110, +180, and +240 minutes after start of THC infusion
Visual Analog Scale (VAS)
Feeling states associated with cannabis intoxication will be measured using a self-reported visual analog scale of feeling states associated with cannabis effects (ex: "high," "calm," "anxious"). Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line. These data will be captured to validate that the experiment is relevant to cannabis effects.
Time frame: Baseline; +15, +110, +180, and +240 minutes after start of THC infusion
Psychotomimetic States Inventory (PSI)
The PSI is a measure of drug induced psychotomimetic states. This self-reported scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC.
Time frame: Baseline; +110, +180, and +240 minutes after start of THC infusion
Cognitive Test Battery
Several computer tasks will be administered in order to evaluate the effects of cannabis on verbal learning and memory, visual recognition, spatial working memory, and working memory. The battery consists of five computer tasks that lasts no longer than 20 minutes in total.
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Placebo dose given intravenously.
Time frame: 25 minutes after start of THC infusion