N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
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ClinicalTrials.gov Identifier: NCT03221231 |
Recruitment Status :
Recruiting
First Posted : July 18, 2017
Last Update Posted : December 8, 2020
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Sponsor:
Universitair Ziekenhuis Brussel
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 19, 2017 | ||||||||
First Posted Date ICMJE | July 18, 2017 | ||||||||
Last Update Posted Date | December 8, 2020 | ||||||||
Actual Study Start Date ICMJE | May 15, 2016 | ||||||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Brain glutamate concentrations [ Time Frame: at study end (2 weeks after study start) ] Glutamate concentrations in the anterior cingulate cortex (ACC)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
75 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | February 1, 2023 | ||||||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |