N-acetylcysteine for the treatment of cannabis dependence: working mechanisms

2024-519855-27-00 Therapeutic use (Phase IV) Ended

Start 15 Jan 2025 · End 17 Feb 2026 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 50
Countries 1
Sites 1

Cannabis dependence

To evaluate the working mechanisms of N-acetylcysteine for the treatment of cannabis dependence

Key facts

Sponsor
UZ Brussel
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration
15 Jan 2025 → 17 Feb 2026
Decision date (initial)
2025-01-15
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Universitair Ziekenhuis Brussel (UZ Brussel)

External identifiers

EU CT number
2024-519855-27-00
EudraCT number
2015-005154-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the working mechanisms of N-acetylcysteine for the treatment of cannabis dependence

Conditions and MedDRA coding

Cannabis dependence

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 Active arm
N-Acetylcysteine
 Randomised Controlled Single [{"id":102725,"code":1,"name":"Subject"}]
2 Placebo arm
Placebo arm
 Randomised Controlled Single [{"id":102727,"code":1,"name":"Subject"}]

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Males, aged 18-45 years
  2. Current DSM-IV diagnosis of cannabis dependence
  3. >1 week detoxified and abstinent
  4. Able to provide written informed consent and to comply with study procedures
  5. Dutch speaking (Dutch as primary language)

Exclusion criteria 7

  1. Currently dependent on any substance other than cannabis, alcohol or nicotine
  2. History of any major internal disease (including diabetes, cardiovascular disease, lung disease, liver or kidney disease)
  3. 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
  4. An active or a history of a psychiatric disorder including, but not limited to, depression, schizophrenia, bipolar disorder, anxiety, or other psychiatric disorders
  5. Asthma
  6. 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)
  7. Exclusion criteria for MRI: having metal in the body and/or having claustrophobia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Day 14 after study start.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Acetylcysteïne Teva 600 mg, poeder voor oraal gebruik

PRD4163113 · Product

Active substance
Acetylcysteine
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL
Max daily dose
2400 mg milligram(s)
Max total dose
2400 mg milligram(s)
Max treatment duration
2 Week(s)
Authorisation status
Authorised
ATC code
R05CB01 — ACETYLCYSTEINE
Marketing authorisation
RVG 13521
MA holder
TEVA NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Placebo Tablet 7mm Lichtenstein

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

20 Total trials 12 Recruiting 3 Ended
Academic / Non-commercial
Sponsor organisation
UZ Brussel
Address
Laarbeeklaan 101
City
Jette
Postcode
1090
Country
Belgium

Scientific contact point

Organisation
UZ Brussel
Contact name
Prof. dr. Cleo L Crunelle

Public contact point

Organisation
UZ Brussel
Contact name
Prof. dr. Cleo L Crunelle

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 50 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Ended
UZ Brussel
Psychiatry, Laarbeeklaan 101, 1090, Jette

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2025-01-15 2025-01-15 2025-02-07

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_ Protocol 2024-519855-27-00 1
Protocol (for publication) D2_Protocol modification nr 2 2024-519855-27-00 1
Recruitment arrangements (for publication) CTR_Transition_Statement_NA 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Acetylcysteine 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-12-30 Belgium Acceptable
2025-01-15
 2025-01-15

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