Impact of tDCS on Cannabis Craving in Schizophrenia (tCCS)

Impact of tDCS on Cannabis Craving in Patients With Schizophrenia and Cannabis Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Cannabis Use Disorder
• Intervention / Treatment: Device: tDCS

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.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BOUAZIZ Noomane, MD; Phone Number: 01 43 09 32 32; Email: urcve@gmail.com
• Study Contact Backup: Name: BENCHERIF Youcef, Project manager; Phone Number: 01 43 09 32 32; Email: y.bencherif@epsve.fr

Study Locations

• France
  • Neuilly sur Marne, France, 93330
    • Youcef Bencherif
    • Contact: Youcef BENCHERIF; Phone Number: 0782723674; Email: bencherif.info@gmail.com
  • Neuilly-sur-Marne, France, 93330
    • Ch Ville Evrard
    • Contact: Dominique Januel, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: 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.
Placebo Comparator: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia	assessment of schizophrenia psychopathology. The minimum value is 7 and the maximum value is 49 for positive scale and negative scale. For general psychopathology, the minimum value is 16 and the maximum value is 112.	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	Assessment of schizophrenia negative symptoms. The total score is the sum of the 20 items, ranging from 0 (no negative symptoms) to 40 (severe 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	CGI scale assess 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	Cannabis craving status assessment. It is a ruler from 0 to 10 : 0 = absence of craving, 1-3 = low craving, 4-6 = moderate craving, 7-9 = intense craving, 10 = extreme craving.	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	Nicotine craving status assessment. It is a ruler from 0 to 10 : 0 = absence of craving, 1-3 = low craving, 4-6 = moderate craving, 7-9 = intense craving, 10 = extreme craving.	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 BART Analogue Risk Task score	BART Analogue Risk assesses risk taking behavior	At baseline (Visit 2) and Day 5 (V6)
change in STROOP Test score	Stroop test assesses continuous attention and inhibition abilities	At baseline (Visit 2) and Day 5 (V6)
Change in Exhaled carbon monoxide concentration score	concentration assessment of monoxide de concentration	At baseline (Visit 2) and Day 5 (V6)
Urinary cannabis test	assessemnt of cannabis presence in urine	between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Cannabis and tobacco use assessement	Assessment of actual use of cannabis and tobacco (numbers of cigarettes, number of joints	At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)
Score to Big Five to assessed the personnality dimensions	The "Big Five" model or the big five personality factors is a tool for personality assessment : extraversion (E), agreeableness (A), conscientiousness (C), neuroticism (N) and openness (O).It is a taxonomic system that measures personality traits. The Bige Five consists of 44 items which are rated on a five-point likert scale from 1 (disagree a lot) to 5 (agree a lot).	Baseline (Visit 2)
Change in MCQ (Marijuana Craving Questionnaire)	The minimum value is 9 and the maximum value is 63.	At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 20, 2027

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: craving; schizophrenia; cannabis; cannabis use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Marijuana Abuse
• Other Study ID Numbers: 10477M-tCCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No