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

Primary Purpose

Cannabis Use Disorder, Cannabis Dependence

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo Oral Tablet
Magnetic Resonance Imaging
Neurocognitive measures
Neuro-inflammatory measures
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis Use Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

  • University Hospital BrusselsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

N-acetylcysteine

Placebo

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

Brain glutamate concentrations
Glutamate concentrations in the anterior cingulate cortex (ACC)

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2017
Last Updated
December 7, 2020
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03221231
Brief Title
N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Official Title
N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2016 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Cannabis Dependence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Healthy controls
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
1200 mg/day, twice daily, N-acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
twice daily, placebo
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Type
Other
Intervention Name(s)
Neurocognitive measures
Intervention Type
Other
Intervention Name(s)
Neuro-inflammatory measures
Primary Outcome Measure Information:
Title
Brain glutamate concentrations
Description
Glutamate concentrations in the anterior cingulate cortex (ACC)
Time Frame
at study end (2 weeks after study start)
Secondary Outcome Measure Information:
Title
Motor impulsivity
Description
Stop Signal Reaction Time (SSRT) on the Stop Signal Task
Time Frame
at study end (2 weeks after study start)
Title
Cognitive impulsivity
Description
Indifference point measured by a Monetary Delayed Discounting Task
Time Frame
at study end (2 weeks after study start)
Title
Attentional Bias
Description
Difference in response time for incongruent-congruent stimuli on a Stroop task
Time Frame
at study end (2 weeks after study start)
Title
Neuro-inflammation
Description
Concentration of interleukin in blood
Time Frame
at study end (2 weeks after study start)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cleo L Crunelle, PhD
Email
nacstudie@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
F Matthys PhD
Facility Information:
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cleo L Crunelle, PhD
Email
nacstudie@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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