Ongoing, recruitingTherapeutic use (Phase IV)Interventional

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

This research study is investigating a medicine called N-acetylcysteine, often shortened to NAC, to understand how it helps people who are dependent on cannabis. Doctors are trying to find out the specific ways NAC works in the body to reduce the desire or need for cannabis. Participants will receive either the NAC medicine or a dummy pill (placebo) to compare the effects. This is a later-stage study, meaning the medicine has already been studied for safety. The goal is to gain a deeper understanding of this potential treatment. It's open to adults aged 18 and older, regardless of their sex. The study will look at changes up to 14 days after it begins.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Brussel

Enrolment target

Start

15 Jan 2025

Cannabis dependence

What is this study about?

This research study is looking at a medicine called N-acetylcysteine, or NAC for short. Its main aim is to understand how this medication works in the body to help people who are dependent on cannabis. Being dependent on cannabis means that someone finds it very hard to stop using it, even if they want to, and it might be causing problems in their life. The researchers want to discover the exact mechanisms by which NAC could help reduce cannabis dependence.

Participants in this study will receive either the active medicine (NAC) or a dummy pill, known as a placebo. A placebo looks exactly like the real medicine but doesn't contain any active ingredients. This is a common way to test medicines, as it helps researchers see if the effects are genuinely from the medicine itself or something else. This study is considered a 'Phase IV' study, which means the medicine has already been through earlier stages of testing for safety and basic effectiveness.

Understanding how NAC works is really important. If doctors can pinpoint the specific ways it helps, it could lead to better and more targeted treatments for cannabis dependence in the future. This study is a step towards finding more effective ways to support people who want to reduce or stop their cannabis use.

Key takeaways

Tests a medicine called N-acetylcysteine (NAC) for cannabis dependence.
Aims to understand how NAC works in the body.
Participants will receive either NAC or a dummy pill (placebo).
Open to adults aged 18 and over, both men and women.
Is a later-stage study, meaning the medicine has previously been tested for safety. This specific study focuses on how it works.
Looks at effects and changes within the first 14 days.

Who may be eligible?

To be part of this study, you need to be an adult, meaning you must be at least 18 years old. There isn't an upper age limit mentioned, so older adults can also take part.

This study is open to both men and women. Your sex will not prevent you from being involved if you meet the other criteria.

Because the study is specifically looking at cannabis dependence, you would need to have been diagnosed with or be experiencing cannabis dependence to be considered for participation.

Quick self-check

Are you 18 years old or older?
Do you feel you are dependent on cannabis?
Are you able to attend study appointments as required?
Are you comfortable potentially receiving a dummy pill (placebo) instead of the active medicine?
Are you a man or a woman?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the research team will explain everything thoroughly. You will attend a few visits to the study clinic, where doctors will check your health and how you are responding. You will be given either the study medicine (N-acetylcysteine) or a placebo (a dummy pill) to take, and you'll need to follow the instructions carefully.

Throughout the study, you'll have appointments for assessments. These might include discussions about your cannabis use, questionnaires, and possibly some simple medical checks. The focus of the study is to see what happens 14 days after you start, so your participation will involve activities leading up to and including that 14-day mark. The total duration of your active involvement in the study will be explained to you in detail by the research team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as gaining access to a new treatment for cannabis dependence that isn't widely available yet, or receiving close medical attention and support during the study. However, there's no guarantee the medicine will help you, especially if you receive the placebo. As with any medicine, there could be side effects from N-acetylcysteine, which the research team will explain fully. They will monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Belgium

Common questions

What is N-acetylcysteine (NAC)?

N-acetylcysteine is a medicine that researchers are studying to see if it can help people who are dependent on cannabis.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the real medicine but doesn't contain any active ingredients. It helps researchers compare effects.

Can anyone join this study?

To join, you must be 18 years old or older and be experiencing cannabis dependence. Both men and women can take part.

What does a 'Phase IV' study mean?

It means the medicine has already been safely tested in earlier stages. This phase focuses on better understanding how it works and its long-term effects.

How long does the study last?

The study specifically looks at effects 14 days after it starts. The full time you'd be involved will be explained by the study team.