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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT03221231
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
80.6
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: N-acetylcysteine
  • Drug: Placebo Oral Tablet
  • Other: Magnetic Resonance Imaging
  • Other: Neurocognitive measures
  • Other: Neuro-inflammatory measures
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCTRCT
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Basic Science
Official Title:
N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Actual Study Start Date :
May 15, 2016
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: N-acetylcysteine

Drug: N-acetylcysteine
1200 mg/day, twice daily, N-acetylcysteine

Other: Magnetic Resonance Imaging

Other: Neurocognitive measures

Other: Neuro-inflammatory measures
Placebo Comparator: Placebo

Drug: Placebo Oral Tablet
twice daily, placebo

Other: Magnetic Resonance Imaging

Other: Neurocognitive measures

Other: Neuro-inflammatory measures
Active Comparator: Healthy controls

Other: Magnetic Resonance Imaging

Other: Neurocognitive measures

Other: Neuro-inflammatory measures

Outcome Measures

Primary Outcome Measures

  1. Brain glutamate concentrations [at study end (2 weeks after study start)]

    Glutamate concentrations in the anterior cingulate cortex (ACC)

Secondary Outcome Measures

  1. Motor impulsivity [at study end (2 weeks after study start)]

    Stop Signal Reaction Time (SSRT) on the Stop Signal Task

  2. Cognitive impulsivity [at study end (2 weeks after study start)]

    Indifference point measured by a Monetary Delayed Discounting Task

  3. Attentional Bias [at study end (2 weeks after study start)]

    Difference in response time for incongruent-congruent stimuli on a Stroop task

  4. Neuro-inflammation [at study end (2 weeks after study start)]

    Concentration of interleukin in blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts 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);

  • Exclusion criteria for MRI: having metal in the body and/or having claustrophobia

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Brussels Brussels Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT03221231
Other Study ID Numbers:
  • 131115
First Posted:
Jul 18, 2017
Last Update Posted:
Dec 8, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Marijuana Abuse
Acetylcysteine
N-monoacetylcystine

Study Results

No Results Posted as of Dec 8, 2020