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

Cannabis Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221231
• Other study ID #: 131115
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Cannabis Dependence
• Cannabis Use Disorder
• Marijuana Abuse

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)