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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 THC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Delta-9-THC and Placebo Pregnenolone | Experimental |
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| Active Delta-9-THC and Active Pregnenolone | Experimental |
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| Placebo Delta-9-THC and Active Pregnenolone | Experimental |
| |
| Placebo Delta-9-THC and Placebo Pregnenolone | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Delta-9-THC | Drug | Active Delta-9-THC (0.036 mg/kg) given intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, +110, +180, and +240 minutes after start of THC Infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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; +15, +110, +180, and +240 minutes after start of THC infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak C D'Souza, MD | Yale University | 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 | A dose given sublingually. |
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| Placebo | Drug | A placebo dose given sublingually. |
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| Placebo | Drug | Placebo dose given intravenously. |
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| 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. | 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. | 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. | 25 minutes after start of THC infusion |