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

December 7, 2020 updated by: Universitair Ziekenhuis Brussel
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: F Matthys PhD

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Recruiting
        • University Hospital Brussels
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Magnetic Resonance Imaging
Other: Neurocognitive measures
Other: Neuro-inflammatory measures
Drug: Placebo Oral Tablet
twice daily, placebo
Active Comparator: Healthy controls
Other: Magnetic Resonance Imaging
Other: Neurocognitive measures
Other: Neuro-inflammatory measures
Experimental: N-acetylcysteine
Other: Magnetic Resonance Imaging
Drug: N-acetylcysteine
1200 mg/day, twice daily, N-acetylcysteine
Other: Neurocognitive measures
Other: Neuro-inflammatory measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain glutamate concentrations
Time Frame: at study end (2 weeks after study start)
Glutamate concentrations in the anterior cingulate cortex (ACC)
at study end (2 weeks after study start)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2016

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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