ChemsexCHEMSTIMNCT05945199
Effectiveness of tDCS on Reducing Craving in Patients Practicing Chemsex: a Single-center, Double-blind, Randomized Controlled Pilot Trial
A study testing tDCS, Assessment of risk behaviours and Scales in people with Chemsex, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemsex
- What is being tested?
- tDCS, Assessment of risk behaviours and Scales
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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 cardiac, neural or drug implants
- Patients with vascular clips or other electrically sensitive support systems in the brain
- Patients with severe brain lesions
- Patients with skin lesions at stimulation sites
- Patients with skin problems such as dermatitis, psoriasis or eczema
- Patients with severe or frequent headaches
- Patients who have already benefited from tDCS sessions
- Pregnant, parturient or breast-feeding women (pregnancy test)
- Staff working in the addictology department of Dijon University Hospital
- Patient participating in another clinical trial
- Patient not affiliated to national health insurance
- Patient unable to complete assessment scales
- Patient under psychiatric care without consent or under legal protection (guardianship, curatorship)
- Major incapable or unable to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon
Benjamin PETIT, 03.80.29.35.24, benjamin.petit@chu-dijon.fr
About this study
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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
- 1 session/day for 5 consecutive days
- stimulation at an intensity of 2 mA for the active tDCS group and sham stimulation (using the device's sham mode) for the placebo group
Assessment of risk behavioursBehavioural
Assessment of risk behaviours (retrospective exploration by the categorical rating of frequency: At least once a day - Several times a week several times a week - once a week - several times a month - once a month - less than once a month - never). times a month - Once a month - Less than once a month - Never)
ScalesOther
EVA craving index for chemsex Maximum VAS craving in the week preceding assessment for chemsex, sexual practices and use of psychoactive substances, HAqII, CSBD-19, modified CCQ-brief, SDI, BDI-II
| Study group | Role | What they receive |
|---|---|---|
| tDCS active | Experimental | Not described Receives: Device: tDCS; Behavioral: Assessment of risk behaviours; Other: Scales |
| Sham tDCS | Placebo comparator | Not described Receives: Device: tDCS; Behavioral: Assessment of risk behaviours; Other: Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cue-induced craving for chemsex using a visual analogue scale
Measured: 4 weeks from end of stimulation (S5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start29 Jul 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemsexStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945199
- Sponsor's protocol ID
- PETIT AOI 2021
- Acronym
- CHEMSTIM
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of tDCS on Reducing Craving in Patients Practicing Chemsex: a Single-center, Double-blind, Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05945199
- Acronym / sponsor ID
- CHEMSTIM / PETIT AOI 2021
- Conditions
- Chemsex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS active | Experimental | Device: tDCS, Behavioral: Assessment of risk behaviours, Other: Scales |
| Sham tDCS | Placebo comparator | Device: tDCS, Behavioral: Assessment of risk behaviours, Other: Scales |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS* 1 session/day for 5 consecutive days * stimulation at an intensity of 2 mA for the active tDCS group and sham stimulation (using the device's sham mode) for the placebo group | Device | Sham tDCS, tDCS active |
| Assessment of risk behavioursAssessment of risk behaviours (retrospective exploration by the categorical rating of frequency: At least once a day - Several times a week several times a week - once a week - several times a month - once a month - less than once a month - never). times a month - Once a month - Less than once a month - Never) | Behavioural | Sham tDCS, tDCS active |
| ScalesEVA craving index for chemsex Maximum VAS craving in the week preceding assessment for chemsex, sexual practices and use of psychoactive substances, HAqII, CSBD-19, modified CCQ-brief, SDI, BDI-II | Other | Sham tDCS, tDCS active |
Primary outcome
Assessment of cue-induced craving for chemsex using a visual analogue scale
Time frame: 4 weeks from end of stimulation (S5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS, Assessment of risk behaviours and Scales in people with Chemsex, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin PETIT (03.80.29.35.24, benjamin.petit@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cue-induced craving for chemsex using a visual analogue scale (time frame: 4 weeks from end of stimulation (S5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.