Actively Recruiting
Effectiveness of tDCS on Reducing Craving in Patients Practicing Chemsex: a Single-center, Double-blind, Randomized Controlled Pilot Trial
Led by Centre Hospitalier Universitaire Dijon · Updated on 2024-07-30
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of tDCS on Reducing Craving in Patients Practicing Chemsex: a Single-center, Double-blind, Randomized Controlled Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who provides written consent
- Patient aged 218 years or older
- Patient motivated and willing to change chemsex behavior, as assessed by examiner during screening and inclusion visits
- Patient uses at least one of the following psychoactive substances to modify sexual performance and/or experience: cathinones, methamphetamine, MDMA, cocaine, ketamine, or GBL/GHB
- Substance use frequency of at least once per month over the past 6 months and/or at least 10 times over the past year
You will not qualify if you...
- Patient with substance use disorder not related to chemsex
- Recent change (less than 1 month) in psychotropic treatment prescription
- Acute psychiatric condition requiring hospitalization or immediate change in psychotropic treatment
- Unstable or uncontrolled neuropsychiatric disease
- History of epileptic seizures
- Unexplained episodes of loss of consciousness
- Advanced or decompensated somatic pathology requiring hospitalization during study follow-up
- Serious life-threatening illness such as congestive heart failure, chronic obstructive pulmonary disease, or active cancer
- Presence of implanted cerebral medical devices, pacemakers, or any electrically, magnetically, or mechanically activated implants
- Cardiac, neural, or drug implants
- Vascular clips or other electrically sensitive devices in the brain
- Severe brain lesions
- Skin lesions at stimulation sites
- Skin problems such as dermatitis, psoriasis, or eczema
- Severe or frequent headaches
- Previous tDCS sessions
- Pregnant, parturient, or breastfeeding women
- Staff working in the addictology department of Dijon University Hospital
- Participation in another clinical trial
- Not affiliated with national health insurance
- Unable to complete assessment scales
- Under psychiatric care without consent or under legal protection (guardianship, curatorship)
- Major incapable or unable to provide consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Dijon Bourgogne
Dijon, France
Actively Recruiting
Research Team
B
Benjamin PETIT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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