Healthy
Conditions
Keywords
Cannabis, Marijuana, THC, Pregnenolone, Psychotic Disorders, PREG
Brief summary
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.
Interventions
Active Delta-9-THC (0.036 mg/kg) given intravenously.
A dose given sublingually.
DRUGPlacebo
A placebo dose given sublingually.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Exposed to cannabis at least once in lifetime.
Exclusion criteria
* Cannabis naive * Individuals with a documented reaction/allergy to Pregnenolone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS) | Baseline, +110, +180, and +240 minutes after start of THC Infusion | Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered Dissociative Symptoms Scale (CADSS) | Baseline; +15, +110, +180, and +240 minutes after start of THC infusion | 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. |
| Visual Analog Scale (VAS) | Baseline; +15, +110, +180, and +240 minutes after start of THC infusion | 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. |
| Psychotomimetic States Inventory (PSI) | Baseline; +110, +180, and +240 minutes after start of THC infusion | 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. |
| Cognitive Test Battery | 25 minutes after start of THC infusion | 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. |
Countries
United States
Outcome results
None listed