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

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 4

Conditions: Cannabis Dependence; Cannabis Use Disorder

Treatments: Other: Neuro-inflammatory measures; Other: Neurocognitive measures; Drug: N-acetylcysteine; Other: Magnetic Resonance Imaging; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03221231

131115

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Treatment:

Other: Magnetic Resonance Imaging

Other: Neuro-inflammatory measures

Drug: N-acetylcysteine

Other: Neurocognitive measures

Placebo

Placebo Comparator group

Treatment:

Other: Magnetic Resonance Imaging

Other: Neuro-inflammatory measures

Drug: Placebo Oral Tablet

Other: Neurocognitive measures

Healthy controls

Active Comparator group

Treatment:

Other: Magnetic Resonance Imaging

Other: Neuro-inflammatory measures

Other: Neurocognitive measures