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N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221231
Recruitment Status : Unknown
Verified June 2017 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : July 18, 2017
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief Summary:
This study investigates the effects of repeated NAC administration on glutamate concentrations in the anterior cingulate cortex (ACC), on neurocognitive functioning, and on neuro-inflammatory parameters in adult cannabis-dependent individuals.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Cannabis Dependence Drug: N-acetylcysteine Drug: Placebo Oral Tablet Other: Magnetic Resonance Imaging Other: Neurocognitive measures Other: Neuro-inflammatory measures Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Actual Study Start Date : May 15, 2016
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: N-acetylcysteine Drug: N-acetylcysteine
1200 mg/day, twice daily, N-acetylcysteine

Other: Magnetic Resonance Imaging
Other: Neurocognitive measures
Other: Neuro-inflammatory measures
Placebo Comparator: Placebo Drug: Placebo Oral Tablet
twice daily, placebo

Other: Magnetic Resonance Imaging
Other: Neurocognitive measures
Other: Neuro-inflammatory measures
Active Comparator: Healthy controls Other: Magnetic Resonance Imaging
Other: Neurocognitive measures
Other: Neuro-inflammatory measures



Primary Outcome Measures :
  1. Brain glutamate concentrations [ Time Frame: at study end (2 weeks after study start) ]
    Glutamate concentrations in the anterior cingulate cortex (ACC)


Secondary Outcome Measures :
  1. Motor impulsivity [ Time Frame: at study end (2 weeks after study start) ]
    Stop Signal Reaction Time (SSRT) on the Stop Signal Task

  2. Cognitive impulsivity [ Time Frame: at study end (2 weeks after study start) ]
    Indifference point measured by a Monetary Delayed Discounting Task

  3. Attentional Bias [ Time Frame: at study end (2 weeks after study start) ]
    Difference in response time for incongruent-congruent stimuli on a Stroop task

  4. Neuro-inflammation [ Time Frame: at study end (2 weeks after study start) ]
    Concentration of interleukin in blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current DSM-IV diagnosis of cannabis dependence, >1 week detoxified and abstinent;
  • Able to provide written informed consent and to comply with study procedures.
  • Dutch speaking (Dutch as primary language).

Exclusion Criteria:

  • Currently dependent on any substance other than cannabis, alcohol or nicotine;
  • History of any major internal disease (including diabetes, cardiovascular disease, lung disease, liver or kidney disease);
  • An active or any history of neurological disorder, including but not limited to seizure disorder, epilepsy, stroke, neurological disease, cognitive impairment, head trauma with prolonged loss of consciousness (>10 minutes), or migraine headaches;
  • An active or a history of a psychiatric disorder including, but not limited to, depression, schizophrenia, bipolar disorder, anxiety, or other psychiatric disorders;
  • Asthma;
  • Known hypersensitivity or allergy to n-acetylcysteine, or receiving chronic therapy with medication that could interact adversely with n-acetylcysteine within 30 days prior to randomization (i.e., nitroglycerin, ACE inhibitors or antihypertensive drugs, anti-coagulants);
  • Exclusion criteria for MRI: having metal in the body and/or having claustrophobia

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): NCT03221231


Contacts
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Contact: Cleo L Crunelle, PhD nacstudie@gmail.com
Contact: F Matthys PhD

Locations
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Belgium
University Hospital Brussels Recruiting
Brussels, Belgium, 1090
Contact: Cleo L Crunelle, PhD       nacstudie@gmail.com   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03221231    
Other Study ID Numbers: 131115
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
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