An Early Phase 1 interventional study of Delta-9-THC and N-acetylcysteine in Healthy, sponsored by Yale University. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-31.
Sponsored by Yale University · Early Phase 1, Interventional, and Basic science
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.
Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Delta-9-THC · Drug: N-acetylcysteine
Drug: Delta-9-THC · Drug: Placebo
Drug: N-acetylcysteine · Drug: Placebo
Drug: Placebo
Active Delta-9-THC (0.036mg/Kg) given intravenously.
A pill given orally.
Placebo (about a quarter spoon of alcohol with no THC) given intravenously.
Placebo "sugar" pill given orally with no N-acetylcysteine.
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
Time frame: -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
Time frame: +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
Time frame: +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
Time frame: +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
Time frame: -60 minutes from administration of THC
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.
Time frame: -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.
Time frame: -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.
Time frame: +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.
Time frame: +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.
Time frame: -60min, -30min, +240min from administration of THC
This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Yale University