N-acetylcysteine Effects on Tetrahydrocannabinol

Study Overview
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Brief Summary
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The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.

Official Title
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Effect of N-acetylcysteine on the Acute Cognitive Effects of Delta-9-Tetrahydrocannabinol

Conditions
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Healthy

Intervention / Treatment
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* Drug: Delta-9-THC
* Drug: N-acetylcysteine
* 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 allergy to N-acetylcysteine

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 N-acetylcysteine and Active Delta-9-THC<br> | Drug: Delta-9-THC<br>* Active Delta-9-THC (0.036mg/Kg) given intravenously.<br>Drug: N-acetylcysteine<br>* A pill given orally.<br>|
| Placebo Comparator: Placebo and Active Delta-9-THC<br> | Drug: Delta-9-THC<br>* Active Delta-9-THC (0.036mg/Kg) given intravenously.<br>Drug: Placebo<br>* Placebo sugar pill given orally with no N-acetylcysteine.<br>|
| Experimental: Active N-acetylcysteine and Placebo<br> | Drug: N-acetylcysteine<br>* A pill given orally.<br>Drug: Placebo<br>* Placebo (about a quarter spoon of alcohol with no THC) given intravenously.<br>|
| Placebo Comparator: Placebo and Placebo<br> | Drug: Placebo<br>* Placebo (about a quarter spoon of alcohol with no THC) given intravenously.<br>Drug: Placebo<br>* Placebo sugar pill given orally with no N-acetylcysteine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Symptom Scale for Schizophrenia (PANSS) | Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS | -30 minutes from administration of THC | 
| Positive and Negative Symptom Scale for Schizophrenia (PANSS) | Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS | +15 minutes from administration of THC | 
| Positive and Negative Symptom Scale for Schizophrenia (PANSS) | Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS | +90 minutes from administration of THC | 
| Positive and Negative Symptom Scale for Schizophrenia (PANSS) | Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS | +240 minutes from administration of THC | 
| Positive and Negative Symptom Scale for Schizophrenia (PANSS) | Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS | -60 minutes from administration of THC | 

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 8 clinician-rated items. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment. | -60min, -30min, +15min, +90min, +240min from administration of THC | 
| 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. | -60min, -30min, +15min, +90min, +240min from administration of THC | 
| Cognitive Test Battery | Several computer tasks will be administered in order to evaluate the effects of cannabis on recognition memory, working memory, and attention. The battery consists of four computer tasks that lasts no longer than 20 minutes in total. | +20min from administration of THC | 
| Hopkins Verbal Learning Test (HVLT) | The HVLT is a 12 word list that is semantically organized. The task consists of 5 trials and a different version of the HVLT will be administered on each test day. | +20min from administration of THC | 
| 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. | -60min, -30min, +240min from administration of THC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cannabis, Marijuana, THC, N-acetylcysteine, Psychotic Disorders