Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone

Study Overview
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Brief Summary
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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.

Official Title
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Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone

Conditions
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Healthy

Intervention / Treatment
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* Drug: Active Delta-9-THC
* Drug: Active Pregnenolone
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exposed to cannabis at least once in lifetime. Exclusion Criteria: Cannabis naive Individuals with a documented reaction/allergy to Pregnenolone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Delta-9-THC and Placebo Pregnenolone<br> | Drug: Active Delta-9-THC<br>* Active Delta-9-THC (0.036 mg/kg) given intravenously.<br>Drug: Placebo<br>* A placebo dose given sublingually.<br>|
| Experimental: Active Delta-9-THC and Active Pregnenolone<br> | Drug: Active Delta-9-THC<br>* Active Delta-9-THC (0.036 mg/kg) given intravenously.<br>Drug: Active Pregnenolone<br>* A dose given sublingually.<br>|
| Experimental: Placebo Delta-9-THC and Active Pregnenolone<br> | Drug: Active Pregnenolone<br>* A dose given sublingually.<br>Drug: Placebo<br>* Placebo dose given intravenously.<br>|
| Placebo Comparator: Placebo Delta-9-THC and Placebo Pregnenolone<br> | Drug: Placebo<br>* A placebo dose given sublingually.<br>Drug: Placebo<br>* Placebo dose given intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis, Marijuana, THC, Pregnenolone, Psychotic Disorders, PREG