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

Phase 4

• Conditions: Cannabis Use Disorder; Cannabis Dependence
• Interventions: Drug: Placebo Oral Tablet; Drug: N-acetylcysteine; Other: Magnetic Resonance Imaging; Other: Neurocognitive measures; Other: Neuro-inflammatory measures

• Registration Number: NCT03221231
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-15
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-18
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-08
• Primary Completion: 2022-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	Neuro-inflammatory measures	-
N-acetylcysteine	Magnetic Resonance Imaging	-
Healthy controls	Neurocognitive measures	-
N-acetylcysteine	Neurocognitive measures	-
N-acetylcysteine	Neuro-inflammatory measures	-
Placebo	Placebo Oral Tablet	-
Placebo	Magnetic Resonance Imaging	-
Placebo	Neurocognitive measures	-
Placebo	Neuro-inflammatory measures	-
Healthy controls	Magnetic Resonance Imaging	-
N-acetylcysteine	N-acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
Brain glutamate concentrations	at study end (2 weeks after study start)	Glutamate concentrations in the anterior cingulate cortex (ACC)

Secondary Outcome Measures

Name	Time	Method
Attentional Bias	at study end (2 weeks after study start)	Difference in response time for incongruent-congruent stimuli on a Stroop task
Neuro-inflammation	at study end (2 weeks after study start)	Concentration of interleukin in blood
Motor impulsivity	at study end (2 weeks after study start)	Stop Signal Reaction Time (SSRT) on the Stop Signal Task
Cognitive impulsivity	at study end (2 weeks after study start)	Indifference point measured by a Monetary Delayed Discounting Task

Trial Locations

Locations (1)

University Hospital Brussels; 🇧🇪 Brussels, Belgium