N-acetylcysteine Effects on Tetrahydrocannabinol

Sponsor

Yale University (Other)

Overall Status

Terminated

CT.gov ID

NCT02335060

Collaborator

(none)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Delta-9-THC Drug: N-acetylcysteine Drug: Placebo Drug: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 2, 2014

Actual Primary Completion Date :

Sep 16, 2014

Actual Study Completion Date :

Sep 16, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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
Positive and Negative Symptom Scale for Schizophrenia (PANSS) [+15 minutes from administration of THC]
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Positive and Negative Symptom Scale for Schizophrenia (PANSS) [+90 minutes from administration of THC]
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
Positive and Negative Symptom Scale for Schizophrenia (PANSS) [+240 minutes from administration of THC]
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
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

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.