NCT03221231

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

5.7 years

First QC Date

June 19, 2017

Last Update Submit

December 7, 2020

Conditions

Cannabis Use DisorderCannabis Dependence

Outcome Measures

Primary Outcomes (1)

  • Brain glutamate concentrations

    Glutamate concentrations in the anterior cingulate cortex (ACC)

    at study end (2 weeks after study start)

Secondary Outcomes (4)

  • Motor impulsivity

    at study end (2 weeks after study start)

  • Cognitive impulsivity

    at study end (2 weeks after study start)

  • Attentional Bias

    at study end (2 weeks after study start)

  • Neuro-inflammation

    at study end (2 weeks after study start)

Study Arms (3)

N-acetylcysteine

EXPERIMENTAL
Drug: N-acetylcysteineOther: Magnetic Resonance ImagingOther: Neurocognitive measuresOther: Neuro-inflammatory measures

Placebo

PLACEBO COMPARATOR
Drug: Placebo Oral TabletOther: Magnetic Resonance ImagingOther: Neurocognitive measuresOther: Neuro-inflammatory measures

Healthy controls

ACTIVE COMPARATOR
Other: Magnetic Resonance ImagingOther: Neurocognitive measuresOther: Neuro-inflammatory measures

Interventions

N-acetylcysteineDRUG

1200 mg/day, twice daily, N-acetylcysteine

N-acetylcysteine
Placebo Oral TabletDRUG

twice daily, placebo

Placebo
Magnetic Resonance ImagingOTHER
Healthy controlsN-acetylcysteinePlacebo
Neurocognitive measuresOTHER
Healthy controlsN-acetylcysteinePlacebo
Neuro-inflammatory measuresOTHER
Healthy controlsN-acetylcysteinePlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brussels

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

AcetylcysteineMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Cleo L Crunelle, PhD

CONTACT

nacstudie@gmail.com

F Matthys PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

July 18, 2017

Study Start

May 15, 2016

Primary Completion

February 1, 2022

Study Completion

February 1, 2023

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations

BE(1)