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N-acetylcysteine Effects on Tetrahydrocannabinol

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ClinicalTrials.gov Identifier: NCT02335060
Recruitment Status : Active, not recruiting
First Posted : January 9, 2015
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Delta-9-THC Drug: N-acetylcysteine Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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
Study Start Date : March 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335060


Locations
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United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Mohini Ranganathan, MD Yale University Medical School

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Responsible Party: Mohini Ranganathan, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT02335060     History of Changes
Other Study ID Numbers: 1402013406
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Keywords provided by Mohini Ranganathan, Yale University:
cannabis
Marijuana
THC
N-acetylcysteine
Psychotic Disorders

Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Dronabinol
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists