Healthy
Conditions
Keywords
cannabis, Marijuana, THC, N-acetylcysteine, Psychotic Disorders
Brief summary
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.
Interventions
DRUGDelta-9-THC
Active Delta-9-THC (0.036mg/Kg) given intravenously.
DRUGN-acetylcysteine
A pill given orally.
DRUGPlacebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Exposed to Cannabis at least once in lifetime
Exclusion criteria
* Cannabis Naive * Individuals with a documented allergy to N-acetylcysteine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptom Scale for Schizophrenia (PANSS) | -30 minutes from administration of THC | Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered Dissociative Symptoms Scale (CADSS) | -60min, -30min, +15min, +90min, +240min from administration of THC | 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. |
| Visual Analog Scale (VAS) | -60min, -30min, +15min, +90min, +240min from administration of THC | 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. |
| Cognitive Test Battery | +20min from administration of THC | 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. |
| Hopkins Verbal Learning Test (HVLT) | +20min from administration of THC | 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. |
| Psychotomimetic States Inventory (PSI) | -60min, -30min, +240min from administration of THC | 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. |
Countries
United States
Outcome results
None listed