N-acetylcysteine Effects on Tetrahydrocannabinol

January 19, 2022 updated by: Mohini Ranganathan, Yale University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Placebo Comparator: Placebo and Active Delta-9-THC
Drug: Delta-9-THC
Active Delta-9-THC (0.036mg/Kg) given intravenously.
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.
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.
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.
Drug: Placebo
Placebo "sugar" pill given orally with no N-acetylcysteine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: -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
-30 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: +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
+15 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: +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
+90 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: +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
+240 minutes from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: -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
-60 minutes from administration of THC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered Dissociative Symptoms Scale (CADSS)
Time Frame: -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.
-60min, -30min, +15min, +90min, +240min from administration of THC
Visual Analog Scale (VAS)
Time Frame: -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.
-60min, -30min, +15min, +90min, +240min from administration of THC
Cognitive Test Battery
Time Frame: +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.
+20min from administration of THC
Hopkins Verbal Learning Test (HVLT)
Time Frame: +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.
+20min from administration of THC
Psychotomimetic States Inventory (PSI)
Time Frame: -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.
-60min, -30min, +240min from administration of THC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Mohini Ranganathan, MD, Yale University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2014

Primary Completion (Actual)

September 16, 2014

Study Completion (Actual)

September 16, 2014

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1402013406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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