Impact of tDCS on Cannabis Craving in Schizophrenia

NCT ID: NCT05784961

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-06-20

Brief Summary

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

Detailed 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.

Conditions

Schizophrenia; Cannabis Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active transcranial direct current stimulation (active tDCS)

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)

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

tDCS will be delivered using this electrode montage: anode on the left dosolateral prefrontal cortex (L DLPFC) using F3 EEG landmark and cathode on the left temporoparietal junction (L TPJ) on the middle point between T3 and P3 EEG landmark.

The stimulation will be delivered at an intensity of 2 milliamps, for 20 minutes, five times a day, with 20 min inter sessions (it will be carried out on 5 consecutive days from Monday to Friday). Each processing day corresponds to a visit of V2, V3, V4, V5 and V6.

Sham tDCS

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

Group Type: PLACEBO_COMPARATOR

tDCS

Intervention Type: DEVICE

tDCS will be delivered using this electrode montage: anode on the left dosolateral prefrontal cortex (L DLPFC) using F3 EEG landmark and cathode on the left temporoparietal junction (L TPJ) on the middle point between T3 and P3 EEG landmark.

The stimulation will be delivered at an intensity of 2 milliamps, for 20 minutes, five times a day, with 20 min inter sessions (it will be carried out on 5 consecutive days from Monday to Friday). Each processing day corresponds to a visit of V2, V3, V4, V5 and V6.

Interventions

tDCS

tDCS will be delivered using this electrode montage: anode on the left dosolateral prefrontal cortex (L DLPFC) using F3 EEG landmark and cathode on the left temporoparietal junction (L TPJ) on the middle point between T3 and P3 EEG landmark.

The stimulation will be delivered at an intensity of 2 milliamps, for 20 minutes, five times a day, with 20 min inter sessions (it will be carried out on 5 consecutive days from Monday to Friday). Each processing day corresponds to a visit of V2, V3, V4, V5 and V6.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de Ville-Evrard, France

OTHER

Sponsor Role: lead

Responsible Party

Noomane Bouaziz, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ch Ville Evrard

Neuilly-sur-Marne, , France

Youcef Bencherif

Neuilly-sur-Marne, , France

Countries

France

Central Contacts

BOUAZIZ Noomane, MD

Role: CONTACT

urcve@gmail.com

01 43 09 32 32

BENCHERIF Youcef, Project manager

Role: CONTACT

y.bencherif@epsve.fr

01 43 09 32 32

Facility Contacts

Dominique Januel, MBBS

Role: primary

Youcef BENCHERIF

Role: primary

bencherif.info@gmail.com

0782723674

Other Identifiers

10477M-tCCS

Identifier Type: -

Identifier Source: org_study_id