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

NCT ID: NCT03221231

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-15

Study Completion Date

2023-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis Use Disorder Cannabis Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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N-acetylcysteine

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

1200 mg/day, twice daily, N-acetylcysteine

Magnetic Resonance Imaging

Intervention Type OTHER

Neurocognitive measures

Intervention Type OTHER

Neuro-inflammatory measures

Intervention Type OTHER

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

twice daily, placebo

Magnetic Resonance Imaging

Intervention Type OTHER

Neurocognitive measures

Intervention Type OTHER

Neuro-inflammatory measures

Intervention Type OTHER

Healthy controls

Group Type ACTIVE_COMPARATOR

Magnetic Resonance Imaging

Intervention Type OTHER

Neurocognitive measures

Intervention Type OTHER

Neuro-inflammatory measures

Intervention Type OTHER

Interventions

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N-acetylcysteine

1200 mg/day, twice daily, N-acetylcysteine

Intervention Type DRUG

Placebo Oral Tablet

twice daily, placebo

Intervention Type DRUG

Magnetic Resonance Imaging

Intervention Type OTHER

Neurocognitive measures

Intervention Type OTHER

Neuro-inflammatory measures

Intervention Type OTHER

Eligibility Criteria

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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);
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Brussels

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Cleo L Crunelle, PhD

Role: CONTACT

Email: [email protected]

F Matthys PhD

Role: CONTACT

Facility Contacts

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Cleo L Crunelle, PhD

Role: primary

Other Identifiers

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131115

Identifier Type: -

Identifier Source: org_study_id