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

NCT05945199 | Recruiting

• 1 other identifier: PETIT AOI 2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemsex

Outcome Measures

Primary Outcomes (1)

• Assessment of cue-induced craving for chemsex using a visual analogue scale

  4 weeks from end of stimulation (S5)

Study Arms (2)

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

Interventions

tDCS DEVICE

* 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

Sham tDCS; tDCS active

Assessment of risk behaviours BEHAVIORAL

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)

Sham tDCS; tDCS active

Scales OTHER

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

Sham tDCS; tDCS active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who provides written consent
• Patient aged ≥ 18 years
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

Chemsex

Interventions

Transcranial Direct Current Stimulation; Weights and Measures

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Investigative Techniques

Central Study Contacts

Benjamin PETIT

CONTACT

03.80.29.35.24; benjamin.petit@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: July 29, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

FR (1)