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

Study Overview
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Brief Summary
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The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.

Official Title
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Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Naloxone
* Drug: Delta-9-THC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one exposure to Cannabis 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 |
| --- | --- |
| Placebo Comparator: Placebo and Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: Active Naloxone and Placebo<br> | Drug: Naloxone<br>* Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push<br>Drug: Placebo<br>* Placebo<br>|
| Placebo Comparator: Placebo and Active Delta-9-THC<br> | Drug: Delta-9-THC<br>* Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Active Naloxone and Active Delta-9-THC<br> | Drug: Naloxone<br>* Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push<br>Drug: Delta-9-THC<br>* Active Delta-9-THC (0.025mg/Kg) 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 and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS). | 4 test days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scales | Will assess subjective effects, perceptual alterations, and cognitive effects. | 4 test days | 
| Clinician Administered Dissociative States Scales (CADSS) | Will measure subjective effects, perceptual alterations, and cognitive effects. | 4 test days | 
| Psychotomimetic States Inventory (PSI) | Will assess subjective effects, perceptual alterations, and cognitive effects. | 4 test days | 
| Marijuana Withdrawal Scale | Will assess subjective effects, perceptual alterations, and cognitive effects. | 4 test days | 
| Clinical Opiate Withdrawal Scale | Will assess subjective effects, perceptual alterations, and cognitive effects. | 4 test days | 
| Marijuana Craving Scale | Will assess subjective effects, perceptual alterations, and cognitive effects. | 4 test days | 
| Neuro cognitive battery | Will assess cognitive effects. | 4 test days | 

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