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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03221231
Enrollment
75
Registered
2017-07-18
Start date
2016-05-15
Completion date
2023-02-01
Last updated
2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Dependence, Cannabis Use Disorder

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.

Interventions

DRUGN-acetylcysteine

1200 mg/day, twice daily, N-acetylcysteine

DRUGPlacebo Oral Tablet

twice daily, placebo

OTHERMagnetic Resonance Imaging
OTHERNeurocognitive measures
OTHERNeuro-inflammatory measures

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

RCT

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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); *

Design outcomes

Primary

MeasureTime frameDescription
Brain glutamate concentrationsat study end (2 weeks after study start)Glutamate concentrations in the anterior cingulate cortex (ACC)

Secondary

MeasureTime frameDescription
Motor impulsivityat study end (2 weeks after study start)Stop Signal Reaction Time (SSRT) on the Stop Signal Task
Cognitive impulsivityat study end (2 weeks after study start)Indifference point measured by a Monetary Delayed Discounting Task
Attentional Biasat study end (2 weeks after study start)Difference in response time for incongruent-congruent stimuli on a Stroop task
Neuro-inflammationat study end (2 weeks after study start)Concentration of interleukin in blood

Countries

Belgium

Contacts

Primary ContactCleo L Crunelle, PhD
nacstudie@gmail.com
Backup ContactF Matthys PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026