Impact of tDCS on Cannabis Craving in Schizophrenia

NCT05784961 | Not Yet Recruiting DMC

• 1 other identifier: 10477M-tCCS
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Schizophrenia; Cannabis Use Disorder

Keywords

cannabis use disorder; schizophrenia; cannabis; craving

Outcome Measures

Primary Outcomes (1)

• Change in Marijuana Craving Questionnaire (MCQ)

  To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63.

  At baseline (Visit 2) and Day 5 (Visit 6)

Secondary Outcomes (12)

• Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia

  At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

• Change in Score of SNS (schizophrenia negative symptoms) to assess negative symptoms

  At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

• Change in Score of CGI (Clinical Global Impression) to clinical outcome

  At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

• Change in VAS score (visual analog scale) to assess the craving to cannabis

  At baseline (Visit 2) and Day 2 (Visit 3), Day 3 (Visit 4),Day 4 (Visit 5), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

• Change in VAS score (visual analog scale) to assessed the craving to nicotine

  At baseline (Visit 2) and Day 2 (Visit 3), Day 3 (Visit 4),Day 4 (Visit 5), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

Study Arms (2)

Active transcranial direct current stimulation (active tDCS)

EXPERIMENTAL

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)

Device: tDCS

Sham tDCS

PLACEBO COMPARATOR

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

Device: tDCS

Interventions

tDCS 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.

Active transcranial direct current stimulation (active tDCS); Sham tDCS

Eligibility Criteria

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

You may qualify if:

• Patients (male or female) aged 18-65
• Patients with schizophrenia according to DSM 5 criteria with Comorbid diagnosis of "cannabis use disorder"
• 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
• Patients without any other drug or psychotherapeutic treatment for cannabis dependence ("naive" patients)
• Reported cannabis use greater than three times per week in the past three years
• Signed consent to participate in research
• Affiliation to a French social security scheme
• Patient fluent in the French language

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (2)

Ch Ville Evrard

Neuilly-sur-Marne, 93330, France

Location

Youcef Bencherif

Neuilly-sur-Marne, 93330, France

Location

MeSH Terms

Conditions

Schizophrenia; Marijuana Abuse

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

BOUAZIZ Noomane, MD

CONTACT

01 43 09 32 32; urcve@gmail.com

BENCHERIF Youcef, Project manager

CONTACT

01 43 09 32 32; y.bencherif@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: tDCS versus sham tDCS

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: March 27, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)