Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I

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 Dronabinol (THC).

Official Title
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Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I

Conditions
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Healthy

Intervention / Treatment
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* Drug: Active Dronabinol
* Drug: Active Pregnenolone
* Drug: Placebo Dronabinol
* Drug: Placebo Pregnenolone


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 naïve Individuals with a documented reaction/allergy to Pregnenolone Individuals with a documented reaction/allergy to Sesame oil

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 THC and Placebo Pregnenolone<br> | Drug: Active Dronabinol<br>* 20 mg capsule of Dronabinol will be administered orally<br>Drug: Placebo Pregnenolone<br>* Control: Placebo given sublingually (under the tongue)<br>|
| Experimental: Active THC and Active Pregnenolone<br> | Drug: Active Dronabinol<br>* 20 mg capsule of Dronabinol will be administered orally<br>Drug: Active Pregnenolone<br>* 1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)<br>|
| Experimental: Placebo THC and Active Pregnenolone<br> | Drug: Active Pregnenolone<br>* 1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)<br>Drug: Placebo Dronabinol<br>* Control: Placebo pill (no active cannabinoids) administered orally<br>|
| Placebo Comparator: Placebo THC and Placebo Pregnenolone<br> | Drug: Placebo Dronabinol<br>* Control: Placebo pill (no active cannabinoids) administered orally<br>Drug: Placebo Pregnenolone<br>* Control: Placebo given sublingually (under the tongue)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

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