N-acetylcysteine Effects on Tetrahydrocannabinol

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02335060
• Other study ID #: 1402013406
• Status: Terminated
• Phase: Early Phase 1
• Start date: May 2, 2014
• Est. completion date: September 16, 2014

Study information

• Verified date: January 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 16, 2014
• Est. primary completion date: September 16, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

• Cannabis Naive

• Individuals with a documented allergy to N-acetylcysteine

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Delta-9-THC
Active Delta-9-THC (0.036mg/Kg) given intravenously.
• N-acetylcysteine
A pill given orally.
• Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously.
• Placebo
Placebo "sugar" pill given orally with no N-acetylcysteine.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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