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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active THC and Placebo Pregnenolone | Experimental |
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| Active THC and Active Pregnenolone | Experimental |
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| Placebo THC and Active Pregnenolone | Experimental |
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| Placebo THC and Placebo Pregnenolone | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Dronabinol | Drug | 20 mg capsule of Dronabinol will be administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline: Positive and Negative Syndrome Scale (PANSS) | Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS. | baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline: 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. | baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak Cyril D'Souza, MD | Yale Univerisity, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine | West Haven | Connecticut | 06516 | United States |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| Active Pregnenolone | Drug | 1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue) |
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| Placebo Dronabinol | Drug | Control: Placebo pill (no active cannabinoids) administered orally |
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| Placebo Pregnenolone | Drug | Control: Placebo given sublingually (under the tongue) |
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| Change from Baseline: 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. This data will be captured to validate the experiment is relevant to cannabis effect. | 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 |
| Change from Baseline: 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. | baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo |
| Cognitive Test Battery | 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. | 25 minutes after Dronabinol is given orally |