Effectiveness of tDCS on Reducing Craving in Patients Practicing Chemsex: a Single-center, Double… (NCT05945199) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of tDCS on Reducing Craving in Patients Practicing Chemsex: a Single-center, Double-blind, Randomized Controlled Pilot Trial
France40 participantsStarted 2024-07-29
Plain-language summary
The aim of this research is to evaluate the efficacy of a new treatment for chemsex or "chemical sex", the use of psychoactive substances to modify sexual experience and performance. This treatment, called Transcranial direct current stimulation (tDCS) aims to modulate the cortical activity of brain areas involved in the desire to use psychoactive substances, or drugs, and the desire for uncontrolled sexual intercourse.
This treatment should therefore lead to a reduction in the craving for consumption of psychoactive substances and/or the practice of uncontrolled sexual activity.
The stakes of this new treatment are high, because chemsex exposes people to health risks for themselves and others. These risks include the risk of infection (skin infections, HIV infection, hepatitis viruses), psychological harms (anxiety attacks, depression, suicide risk), risk of addiction (addiction to the psychoactive product used, sex addiction), and toxicological harm (overdose, dangerous combination of psychoactive substances) or trauma (blows, trauma to the genitals or anorectal trauma).
To date, there is no proven therapeutic treatment for people wishing to reduce or stop chemsex.
40 participants will be randomized into 2 groups:
* 20 patients will receive active stimulation
* 20 patients will receive sham stimulation
The total duration of the study for each patient will be 13 weeks: 1 week of stimulation and 12 weeks of follow-up.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient who provides written consent
* Patient aged ≥ 18 years
* Patient motivated and willing to change chemsex behavior, assessed by examiner during screening and inclusion visits
* Patient using at least one of the following psychoactive substances to modify sexual performance and/or experience:
* Cathinones, or methamphetamine, or MDMA, or cocaine, or ketamine, or GBL/GHB
* ≥ 1 time per month over the past 6 months and/or ≥ 10 times over the past year
Exclusion Criteria:
* Patient with a substance use disorder not involved in the practice of chemsex
* Patient with a recent change (\< 1 month) in the prescription of a psychotropic treatment
* Patient presenting an acute psychiatric condition requiring hospitalization and/or immediate modification of a psychotropic treatment
* Patients with unstable or uncontrolled neuropsychiatric disease
* Patients with a history of epileptic seizures
* Patients with unexplained episodes of loss of consciousness, as this condition may be linked to cerebral alterations or epilepsy
* Patients with advanced or decompensated somatic pathology, requiring hospitalization expected during study follow-up
* Patients suffering from any serious life-threatening illness, such as congestive heart failure, chronic obstructive pulmonary disease or active neoplasia
* Patients with implanted cerebral medical devices, implanted pacemakers, or any electrically, magnetically or mechanically activated implant.
* Patients with car…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of cue-induced craving for chemsex using a visual analogue scale