Healthy
Conditions
Keywords
Cannabis, Marijuana, THC, Dronabinol, Pregnenolone, PREG, Psychotic Disorders
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 Dronabinol (THC).
Interventions
20 mg capsule of Dronabinol will be administered orally
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Control: Placebo pill (no active cannabinoids) administered orally
Control: Placebo given sublingually (under the tongue)
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 naïve * Individuals with a documented reaction/allergy to Pregnenolone * Individuals with a documented reaction/allergy to Sesame oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline: Positive and Negative Syndrome Scale (PANSS) | baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo | Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS) | baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo | 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. |
| Change from Baseline: Visual Analog Scale (VAS) | Baseline; 30 minutes and 10 minutes prior to administration of oral dronabinol or placebo; 20, 90, 110, 150, 180, and 240 minutes after the administration of oral dronabinol/placebo | 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. This data will be captured to validate the experiment is relevant to cannabis effect. |
| Change from Baseline: Psychotomimetic States Inventory (PSI) | baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo | 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 Dronabinol is given orally | Several computer tasks will be administered in order to evaluate the effects of cannabis on verbal learning and memory. The battery consists of five computer tasks that last no longer than 20 minutes in total. |
Countries
United States
Outcome results
None listed