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Impact of tDCS on Cannabis Craving in Schizophrenia (tCCS)

Primary Purpose

Schizophrenia, Cannabis Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tDCS
Sponsored by
Centre hospitalier de Ville-Evrard, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring cannabis use disorder, schizophrenia, cannabis, craving

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Youcef Bencherif
  • Ch Ville EvrardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active transcranial direct current stimulation (active tDCS)

Sham tDCS

Arm 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)

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

Outcomes

Primary Outcome Measures

Change in Marijuana Craving Questionnaire (MCQ)
To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63.

Secondary Outcome Measures

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.
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).
Change in Score of CGI (Clinical Global Impression) to clinical outcome
CGI scale assess clinical outcome
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.
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.
Change in BART Analogue Risk Task score
BART Analogue Risk assesses risk taking behavior
change in STROOP Test score
Stroop test assesses continuous attention and inhibition abilities
Change in Exhaled carbon monoxide concentration score
concentration assessment of monoxide de concentration
Urinary cannabis test
assessemnt of cannabis presence in urine
Cannabis and tobacco use assessement
Assessment of actual use of cannabis and tobacco (numbers of cigarettes, number of joints
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).
Change in MCQ (Marijuana Craving Questionnaire)
The minimum value is 9 and the maximum value is 63.

Full Information

First Posted
October 17, 2021
Last Updated
March 23, 2023
Sponsor
Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT05784961
Brief Title
Impact of tDCS on Cannabis Craving in Schizophrenia
Acronym
tCCS
Official Title
Impact of tDCS on Cannabis Craving in Patients With Schizophrenia and Cannabis Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
April 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cannabis Use Disorder
Keywords
cannabis use disorder, schizophrenia, cannabis, craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
tDCS versus sham tDCS
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active transcranial direct current stimulation (active tDCS)
Arm Type
Experimental
Arm 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)
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Marijuana Craving Questionnaire (MCQ)
Description
To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63.
Time Frame
At baseline (Visit 2) and Day 5 (Visit 6)
Secondary Outcome Measure Information:
Title
Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia
Description
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.
Time Frame
At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Title
Change in Score of SNS (schizophrenia negative symptoms) to assess negative symptoms
Description
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).
Time Frame
At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Title
Change in Score of CGI (Clinical Global Impression) to clinical outcome
Description
CGI scale assess clinical outcome
Time Frame
At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Title
Change in VAS score (visual analog scale) to assess the craving to cannabis
Description
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.
Time Frame
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)
Title
Change in VAS score (visual analog scale) to assessed the craving to nicotine
Description
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.
Time Frame
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)
Title
Change in BART Analogue Risk Task score
Description
BART Analogue Risk assesses risk taking behavior
Time Frame
At baseline (Visit 2) and Day 5 (V6)
Title
change in STROOP Test score
Description
Stroop test assesses continuous attention and inhibition abilities
Time Frame
At baseline (Visit 2) and Day 5 (V6)
Title
Change in Exhaled carbon monoxide concentration score
Description
concentration assessment of monoxide de concentration
Time Frame
At baseline (Visit 2) and Day 5 (V6)
Title
Urinary cannabis test
Description
assessemnt of cannabis presence in urine
Time Frame
between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Title
Cannabis and tobacco use assessement
Description
Assessment of actual use of cannabis and tobacco (numbers of cigarettes, number of joints
Time Frame
At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)
Title
Score to Big Five to assessed the personnality dimensions
Description
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).
Time Frame
Baseline (Visit 2)
Title
Change in MCQ (Marijuana Craving Questionnaire)
Description
The minimum value is 9 and the maximum value is 63.
Time Frame
At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BOUAZIZ Noomane, MD
Phone
01 43 09 32 32
Email
urcve@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
BENCHERIF Youcef, Project manager
Phone
01 43 09 32 32
Email
y.bencherif@epsve.fr
Facility Information:
Facility Name
Youcef Bencherif
City
Neuilly sur Marne
ZIP/Postal Code
93330
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youcef BENCHERIF
Phone
0782723674
Email
bencherif.info@gmail.com
Facility Name
Ch Ville Evrard
City
Neuilly-sur-Marne
ZIP/Postal Code
93330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Januel, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of tDCS on Cannabis Craving in Schizophrenia

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