RecruitingNAINTERVENTIONAL

Effectiveness of tDCS on Reducing Craving in Patients Practicing Chemsex: a Single-center, Double-blind, Randomized Controlled Pilot Trial

This research is testing a new way to help people who engage in 'chemsex', which means using drugs to change their sexual experiences. The treatment is called tDCS, or 'transcranial direct current stimulation'. It involves applying very gentle electrical currents to specific areas of the brain that are linked to cravings for drugs and uncontrolled sexual behaviour. The idea is to see if this can reduce the desire to use drugs during sex, or to have risky sex. Chemsex can lead to serious health problems, including infections, mental health issues, addiction, and even overdose. Currently, there isn't a proven treatment to help people stop. This study will involve 40 people for 13 weeks to see if tDCS can make a difference.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

Start

29 Jul 2024

Estimated completion

01 Aug 2026

Chemsex

What is this study about?

This study is looking at a new treatment for something called 'chemsex'. Chemsex is when people use certain drugs, like crystal meth, mephedrone, or GBL/GHB, to change their sexual experiences. While it might start as a choice, chemsex can lead to serious health issues. These can include getting infections like HIV or hepatitis, struggling with anxiety or depression, becoming addicted to the drugs, or even experiencing overdoses or injuries. At the moment, there isn't one clear treatment that has been proven to help people who want to reduce or stop chemsex.

This research is trying out a treatment called 'transcranial direct current stimulation', or tDCS for short. Don't worry, it's not as scary as it sounds! It involves placing electrodes (small pads) on the head, which deliver a very mild electrical current. This current is designed to gently nudge the activity of certain brain areas. These brain areas are thought to play a role in why people crave drugs and why they might engage in uncontrolled sexual behaviour. The hope is that by adjusting this brain activity, people's desire to use drugs in sexual settings, and to have risky sex, will lessen.

We are hoping this treatment could offer a new option for people needing help. The study will involve 40 participants and will compare the actual tDCS treatment with a 'sham' treatment (where people think they are getting the treatment but aren't) to see if the real treatment makes a difference. Each person will be involved for about 13 weeks in total.

Key takeaways

This study is testing a gentle brain stimulation treatment (tDCS) for people who engage in chemsex.
It aims to reduce cravings for drugs and risky sexual behaviour linked to chemsex.
Chemsex can lead to serious health issues, and there's currently no proven treatment.
Participation lasts 13 weeks, including one week of treatment.
You have a 50/50 chance of receiving the active treatment or a 'sham' (inactive) treatment.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and be willing to give your written permission to take part. You should also be someone who uses drugs like cathinones, methamphetamine, MDMA, cocaine, ketamine, or GBL/GHB for sex. This would mean using them at least once a month in the last six months, or at least ten times in the last year. Importantly, you must also genuinely want to change your chemsex behaviour.

There are also some reasons why you might *not* be able to join. For example, if you have a drug problem that isn't linked to sex, or if you've recently changed your mental health medication. We also can't include you if you have serious mental health conditions that need urgent care, certain brain conditions like epilepsy or issues that cause you to lose consciousness, or a serious active illness like severe heart failure or active cancer. If you have any metal or electrical implants in your body (like a pacemaker or a brain implant), or certain skin conditions on your head, you also wouldn't be able to take part. Unfortunately, pregnant or breastfeeding women also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you use drugs like methamphetamine, mephedrone, or GHB/GBL for sex at least once a month or 10 times a year?
Are you truly motivated to reduce or stop your chemsex behaviour?
Do you have any metal or electrical implants in your body (like a pacemaker)?
Are you currently pregnant or breastfeeding?
Do you have a history of conditions like epilepsy or other serious brain problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for a total of 13 weeks. For one of those weeks, you'll receive the tDCS treatment (or the sham treatment, if you're in that group). After this first week, we'll keep in touch with you for another 12 weeks to see how you're doing. During this time, we'll ask you to answer questions and complete assessments about your behaviour and cravings. This will help us understand if the treatment has had any effect. We'll be looking at things like risk behaviours and using scales to measure changes. You won't be given any study medication, only the tDCS or sham device sessions.

Potential risks and benefits

Taking part in any study has potential upsides and downsides. A potential benefit of joining this study is that the tDCS treatment might help reduce your cravings for drugs and risky sexual behaviour, potentially improving your overall health and well-being. However, there's no guarantee the treatment will work for you, and you might receive the 'sham' treatment which has no active effect. Potential risks associated with tDCS are generally mild, such as slight skin irritation under the electrodes or a headache. More serious risks are very rare but could include seizures in people prone to them. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting

Common questions

What is 'chemsex'?

Chemsex is when people use certain drugs (like meth, mephedrone, MDMA, cocaine, ketamine, or GBL/GHB) specifically to enhance or extend their sexual experiences.

What is tDCS?

tDCS stands for 'transcranial direct current stimulation'. It's a non-invasive treatment that uses a very mild electrical current through electrodes on your head to gently adjust brain activity.

Will I get the real treatment?

Because it's a 'randomised controlled trial', you have a 50/50 chance of getting the active tDCS treatment or a 'sham' treatment, which feels similar but has no active effect. This helps us see if the real treatment works.

How long will I be involved?

You'll be involved in the study for 13 weeks in total. This includes one week of the treatment sessions and 12 weeks where we follow up on your progress.

Can I stop participating if I want to?

Yes, absolutely. You can choose to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Benjamin PETIT

benjamin.petit@chu-dijon.fr 03.80.29.35.24 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.