Impact of tDCS on Cannabis Craving in Schizophrenia (tCCS)

Centre hospitalier de Ville-Evrard, France

Status: Not yet enrolling

Conditions: Cannabis Use Disorder; Schizophrenia

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05784961

10477M-tCCS

Details and patient eligibility

About

This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.

Full description

The authors set up this randomized, double-blind multicenter study. 7 centers are participating in this research. After randomisation, the patient will have either the placebo or stimulation sessions, by tDCS, 5 session per day, for 5 days. The authors use the Marijuana Craving Questionnaire (MCQ) scale to determine the variation in cannabis craving and measure the impact of treatment on craving, as primary outcome.

secondary objectives include assessing the effect of tDCS on the general psychopathology of schizophrenia, cannabis and tobacco addiction, and on cognitive tests assessing attention and risk taking This study will be the first known multicenter study assessing tDCS impact on cannabis craving in schizophrenia.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients (male or female) aged 18-65

2. Patients with schizophrenia according to DSM 5 criteria with Comorbid diagnosis of "cannabis use disorder"

3. Stabilized patients: total score = 80 at initial PANSS score and = 3 at the following PANSS points:

   • conceptual disorganization
   • distrust
   • hallucinatory behaviour
   • Unusual content of thought

4. Patients without any other drug or psychotherapeutic treatment for cannabis dependence ("naive" patients)

5. Reported cannabis use greater than three times per week in the past three years

6. Signed consent to participate in research

7. Affiliation to a French social security scheme

8. Patient fluent in the French language

Exclusion criteria

1. Presence of any other psychiatric disorder, as per DSM-5 criteria.
2. Pregnancy, possible pregnancy due to lack of contraception, breastfeeding.
3. Currently active suicidal or self-injurious ideation (suicidal or not)
4. Patients with Serious medical codition
5. Other "moderate" to "severe" addictions, according to DSM 5 criteria (excluding tobacco and coffee).
6. Contraindications to tDCS (presence of intracranial metal material, intracranial hypertension, etc.).
7. Subjects already treated by tDCS
8. Patients under legal guardianship (except under curatorship)
9. Patients under safeguard of justice

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups, including a placebo group

Active transcranial direct current stimulation (active tDCS)

Experimental group

Description:

The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the L DLPFG and the cathode over the left temporo-parietal junction (L TPJ)

Treatment:

Device: tDCS

Sham tDCS

Placebo Comparator group

Description:

Sham Comparator: sham transcranial direct current stimulation tDCS device allows sham stimulation. tDCS device sham technology allows optimum placebo stimulation via the same stimulation impresssion than active stimulation. Electrode placement is the same than the active arm

Treatment:

Device: tDCS