N-acetylcysteine Effects on Tetrahydrocannabinol

Early Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Delta-9-THC; Drug: Placebo; Drug: N-acetylcysteine

• Registration Number: NCT02335060
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-02
• Primary Completion: 2014-09-16
• Study Completion: 2014-09-16
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Exposed to Cannabis at least once in lifetime

Exclusion Criteria

• Cannabis Naive
• Individuals with a documented allergy to N-acetylcysteine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo and Active Delta-9-THC	Placebo	-
Active N-acetylcysteine and Placebo	Placebo	-
Placebo and Placebo	Placebo	-
Active N-acetylcysteine and Active Delta-9-THC	Delta-9-THC	-
Active N-acetylcysteine and Active Delta-9-THC	N-acetylcysteine	-
Placebo and Active Delta-9-THC	Delta-9-THC	-
Active N-acetylcysteine and Placebo	N-acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
Positive and Negative Symptom Scale for Schizophrenia (PANSS)	-60 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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States