The Effects of Cannabidiol and ∆-9-THC in Humans

Study Overview
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Brief Summary
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Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.

Official Title
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Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cannabidiol
* Drug: Delta-9-THC
* 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

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 Canabidiol and Active Delta-9-THC<br> | Drug: Cannabidiol<br>* Active Cannabidiol 5mg.<br>Drug: Delta-9-THC<br>* Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or joint.<br>|
| Placebo Comparator: Placebo and Active Delta-9-THC<br> | Drug: Delta-9-THC<br>* Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or joint.<br>Drug: Placebo<br>* Placebo (about a quarter spoon of alcohol with no CBD).<br>|
| Experimental: Active Cannabidiol and Placebo<br> | Drug: Cannabidiol<br>* Active Cannabidiol 5mg.<br>Drug: Placebo<br>* Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.<br>|
| Placebo Comparator: Placebo and Placebo<br> | Drug: Placebo<br>* Placebo (about a quarter spoon of alcohol with no CBD).<br>Drug: Placebo<br>* Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Measures | Subjective effects, perceptual alterations, and cognitive effects will be assessed using visual analog scales, Positive and Negative Symptom Subscale (PANSS), Clinician Administered Dissociative States Scale (CADSS), Psychotomimetic States Inventory (PSI) and a neuro cognitive battery. | Baseline, +15, +80, +240 | 

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