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Study on How N-acetylcysteine Helps Treat Cannabis Addiction in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of cannabis dependence and how it can be treated using a medication called N-acetylcysteine. Cannabis dependence is a condition where a person finds it difficult to stop using cannabis, even if it causes problems in their life. The study aims to understand how N-acetylcysteine, which is a chemical substance, can help people who are dependent on cannabis.

Participants in the study will receive either N-acetylcysteine or a placebo, which looks like the medication but does not contain the active substance. The study will last for a short period, and participants will be monitored to see how the treatment affects their cannabis dependence. The goal is to evaluate the working mechanisms of N-acetylcysteine in helping individuals reduce their dependence on cannabis.

Throughout the study, participants will take the medication in the form of an oral solution, which means it is taken by mouth. The study will help researchers understand if N-acetylcysteine can be an effective treatment for those struggling with cannabis dependence, potentially offering a new way to support individuals in overcoming this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of cannabis dependence, and ensuring a detoxified and abstinent state for more than one week.
Participants must be able to provide written informed consent and comply with study procedures. Proficiency in Dutch is required.
Step 2
Medication administration
Participants receive either Acetylcysteine or a placebo. The medication is provided in the form of a 600 mg oral solution.
The medication is taken as directed by the study team, with specific instructions on dosage and frequency provided during the trial.
Step 3
Monitoring and evaluation
Participants are monitored throughout the trial to evaluate the effects of the medication on cannabis dependence.
The primary endpoint for evaluation is set for day 14 after the study start.
Step 4
Completion of trial
The trial is estimated to conclude by December 31, 2025. Participants will be informed of the study's findings and any relevant outcomes.

Who can join the trial?

6 criteria

Participants must be **males** aged between **18 and 45 years**.
Participants must have a current **DSM-IV diagnosis** of **cannabis dependence**. This means they have been diagnosed with a condition where they rely on cannabis.
Participants must be **detoxified** and have not used cannabis for more than **1 week**. Detoxified means they have cleared cannabis from their body.
Participants must be able to provide **written informed consent**. This means they understand the study and agree to participate.
Participants must be able to **comply with study procedures**. This means they can follow the rules and steps of the study.
Participants must speak **Dutch** as their primary language.

Who cannot join the trial?

3 criteria

Individuals who are not dependent on cannabis cannot participate. Cannabis dependence means having a strong need to use cannabis regularly, even if it causes problems in daily life.
People who are under 18 years old cannot join the study.
Individuals who are part of a vulnerable population, such as those who might not be able to make decisions for themselves, are not eligible.

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Verified sites

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Vrije Universiteit Brussel
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Jette, Belgium

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Investigated drugs

N-acetylcysteine is being studied for its potential to help people who are dependent on cannabis. It is believed to work by affecting certain chemicals in the brain, which may help reduce cravings and improve the ability to stop using cannabis.

Acetylcysteine

What is already known about the treatment

N-acetylcysteine – N-acetylcysteine is administered orally, typically in tablet or capsule form. It is currently being studied in clinical trials for its potential use in treating cannabis dependence. The main therapeutic indication being explored is its ability to help individuals reduce or overcome their dependence on cannabis. At the molecular level, N-acetylcysteine works by replenishing levels of glutathione, an antioxidant that helps reduce oxidative stress, and modulating glutamate levels in the brain, which may influence addictive behaviors. It is classified pharmacologically as a mucolytic agent and antioxidant.

Investigated diseases

Cannabis Dependence – Cannabis dependence is a condition characterized by a strong desire to use cannabis, difficulties in controlling its use, and continued use despite harmful consequences. Individuals may experience increased tolerance, needing more of the substance to achieve the same effects. Withdrawal symptoms can occur when cannabis use is reduced or stopped, including irritability, sleep difficulties, and decreased appetite. The condition can lead to neglect of responsibilities and activities, as well as social or interpersonal problems. Over time, the dependence can affect various aspects of life, including mental and physical health.