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

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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

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date October 24, 2018
Actual Study Start Date  ICMJE May 15, 2016
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
Brain glutamate concentrations [ Time Frame: at study end (2 weeks after study start) ]
Glutamate concentrations in the anterior cingulate cortex (ACC)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • Motor impulsivity [ Time Frame: at study end (2 weeks after study start) ]
    Stop Signal Reaction Time (SSRT) on the Stop Signal Task
  • Cognitive impulsivity [ Time Frame: at study end (2 weeks after study start) ]
    Indifference point measured by a Monetary Delayed Discounting Task
  • Attentional Bias [ Time Frame: at study end (2 weeks after study start) ]
    Difference in response time for incongruent-congruent stimuli on a Stroop task
  • Neuro-inflammation [ Time Frame: at study end (2 weeks after study start) ]
    Concentration of interleukin in blood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Official Title  ICMJE N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
RCT
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE
  • Cannabis Use Disorder
  • Cannabis Dependence
Intervention  ICMJE
  • Drug: N-acetylcysteine
    1200 mg/day, twice daily, N-acetylcysteine
  • Drug: Placebo Oral Tablet
    twice daily, placebo
  • Other: Magnetic Resonance Imaging
  • Other: Neurocognitive measures
  • Other: Neuro-inflammatory measures
Study Arms  ICMJE
  • Experimental: N-acetylcysteine
    Interventions:
    • Drug: N-acetylcysteine
    • Other: Magnetic Resonance Imaging
    • Other: Neurocognitive measures
    • Other: Neuro-inflammatory measures
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo Oral Tablet
    • Other: Magnetic Resonance Imaging
    • Other: Neurocognitive measures
    • Other: Neuro-inflammatory measures
  • Active Comparator: Healthy controls
    Interventions:
    • Other: Magnetic Resonance Imaging
    • Other: Neurocognitive measures
    • Other: Neuro-inflammatory measures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2019
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03221231
Other Study ID Numbers  ICMJE 131115
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Universitair Ziekenhuis Brussel
Study Sponsor  ICMJE Universitair Ziekenhuis Brussel
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitair Ziekenhuis Brussel
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP