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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03221231
Other study ID # 131115
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 15, 2016
Est. completion date February 1, 2023

Study information

Verified date December 2020
Source Universitair Ziekenhuis Brussel
Contact Cleo L Crunelle, PhD
Email nacstudie@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date February 1, 2023
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
N-acetylcysteine
1200 mg/day, twice daily, N-acetylcysteine
Placebo Oral Tablet
twice daily, placebo
Other:
Magnetic Resonance Imaging

Neurocognitive measures

Neuro-inflammatory measures


Locations

Country Name City State
Belgium University Hospital Brussels Brussels

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain glutamate concentrations Glutamate concentrations in the anterior cingulate cortex (ACC) at study end (2 weeks after study start)
Secondary Motor impulsivity Stop Signal Reaction Time (SSRT) on the Stop Signal Task at study end (2 weeks after study start)
Secondary Cognitive impulsivity Indifference point measured by a Monetary Delayed Discounting Task at study end (2 weeks after study start)
Secondary Attentional Bias Difference in response time for incongruent-congruent stimuli on a Stroop task at study end (2 weeks after study start)
Secondary Neuro-inflammation Concentration of interleukin in blood at study end (2 weeks after study start)
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