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Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia (CANNAPSYSTIM)

Primary Purpose

Schizophrenia, Cannabis-Induced Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS) active
Transcranial direct current stimulation (tDCS) non active
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring dorsolateral prefrontal cortex, medial prefrontal cortex, schizophrenia, cannabis-induced disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Schizophrenia diagnostic according to DSM (Diagnostic and Statistical Manual of mental disorder) 5 criteria, without change in psychotropic treatment since at least 4 weeks
  • Moderate to severe cannabis use disorder according to DSM 5 criteria and active consumption during the last 7 days
  • Subjects motivated to reduce or quit their cannabis consumption
  • Patients with ambulatory compulsory care may be included

Exclusion Criteria:

  • Other substance use disorder, excluding nicotine, according to DSM 5 criteria
  • Other current psychiatric disorder according to DSM 5 criteria, excluding personality disorder
  • Inpatient hospitalization
  • History of head injury, neurological disorder with cerebral consequence or severe unstable somatic disorder
  • Pregnancy or no contraception
  • Contraindications for tDCS and/or MRI (implanted material, uncontrolled epilepsy, intracranial hypertension)

Sites / Locations

  • CH Le Vinatier Service universitaire d'addictologie de Lyon
  • Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles
  • CHU de Clermont-Ferrand Service de Psychiatrie
  • Service Hospitalo-Universitaire d'Addictologie CHU de Dijon
  • CHU Pôle de Psychiatrie Neurologie et Rééducation
  • CH Saint-Cyr-au-Mont-d'Or service de psychiatrie
  • CHU de Saint-EtienneRecruiting
  • Centre Hospitalier Alpes Isère

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active tDCS stimulation

sham tDCS stimulation

Arm Description

Transcranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus

Transcranial direct current stimulation tDCS-The control group will receive the sham stimulation following the same regimen, using the sham procedure .

Outcomes

Primary Outcome Measures

cannabis use
Percentage change in cannabis use before and after tDCS treatment

Secondary Outcome Measures

cannabis use
Percentage change in cannabis use before and after 3 months tDCS treatment
Change in craving scores
Marijuana Craving Questionnaire score (minimum =12, maximum = 84). The higher the score, the greater the craving.
Hospitalizations
Number of hospitalization(s) during the 6 months after tDCS sessions
Study of structural cerebral connectivity
Cerebral MRI (only for a subgroup of patients) : Diffusion of water at the white matter level for the evaluation of structural brain connectivity in DTI mode (diffusion tensor) on
Study of structural and functional cerebral connectivity
Cerebral MRI (only for a subgroup of patients) : Functional connectivity index evaluated by resting state default mode network (MRI) for the evaluation of functional brain connectivity

Full Information

First Posted
April 23, 2021
Last Updated
February 20, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Direction Générale de l'Offre de Soins
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1. Study Identification

Unique Protocol Identification Number
NCT04871048
Brief Title
Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia
Acronym
CANNAPSYSTIM
Official Title
Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Direction Générale de l'Offre de Soins

4. Oversight

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

5. Study Description

Brief Summary
Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.
Detailed Description
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays. The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cannabis-Induced Disorder
Keywords
dorsolateral prefrontal cortex, medial prefrontal cortex, schizophrenia, cannabis-induced disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays. The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
Masking
ParticipantCare Provider
Masking Description
active tDCS stimulation. Patients will receive 10 sessions of tDCS over 5 consecutive days, at a frequency of 2 sessions per day spaced at least two hours apart, at an intensity of 2mA, for 20 minutes each. tDCS placebo stimulation. Patients will receive 10 sessions of tDCS over 5 consecutive days, at a frequency of 2 sessions per day spaced at least two hours apart, following an identical procedure (tracking, then wearing the device for 20 minutes) but with actual stimulation provided during the first 40 seconds.
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS stimulation
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus
Arm Title
sham tDCS stimulation
Arm Type
Sham Comparator
Arm Description
Transcranial direct current stimulation tDCS-The control group will receive the sham stimulation following the same regimen, using the sham procedure .
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS) active
Intervention Description
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS) non active
Intervention Description
The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
Primary Outcome Measure Information:
Title
cannabis use
Description
Percentage change in cannabis use before and after tDCS treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
cannabis use
Description
Percentage change in cannabis use before and after 3 months tDCS treatment
Time Frame
3 months
Title
Change in craving scores
Description
Marijuana Craving Questionnaire score (minimum =12, maximum = 84). The higher the score, the greater the craving.
Time Frame
3 months and 6 months
Title
Hospitalizations
Description
Number of hospitalization(s) during the 6 months after tDCS sessions
Time Frame
6 months
Title
Study of structural cerebral connectivity
Description
Cerebral MRI (only for a subgroup of patients) : Diffusion of water at the white matter level for the evaluation of structural brain connectivity in DTI mode (diffusion tensor) on
Time Frame
3 months
Title
Study of structural and functional cerebral connectivity
Description
Cerebral MRI (only for a subgroup of patients) : Functional connectivity index evaluated by resting state default mode network (MRI) for the evaluation of functional brain connectivity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Schizophrenia diagnostic according to DSM (Diagnostic and Statistical Manual of mental disorder) 5 criteria, without change in psychotropic treatment since at least 4 weeks Moderate to severe cannabis use disorder according to DSM 5 criteria and active consumption during the last 7 days Subjects motivated to reduce or quit their cannabis consumption Patients with ambulatory compulsory care may be included Exclusion Criteria: Other substance use disorder, excluding nicotine, according to DSM 5 criteria Other current psychiatric disorder according to DSM 5 criteria, excluding personality disorder Inpatient hospitalization History of head injury, neurological disorder with cerebral consequence or severe unstable somatic disorder Pregnancy or no contraception Contraindications for tDCS and/or MRI (implanted material, uncontrolled epilepsy, intracranial hypertension)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelia GAY, MD
Phone
(0)4 77 82 88 50
Ext
+33
Email
aurelia.gay@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Béatrice DEYGAS
Email
beatrice.deygas@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelia GAY, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Le Vinatier Service universitaire d'addictologie de Lyon
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin ROLLAND, PHD
Phone
(0)437915075
Ext
+33
Email
benjamin.rolland@ch-le-vinatier.fr
Facility Name
Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges BROUSSE, PHD
Phone
(0)473752072
Ext
+33
Email
gbrousse@chu-clermontferrand.fr
Facility Name
CHU de Clermont-Ferrand Service de Psychiatrie
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Michel LLORCA, PHD
Phone
(0)473752125
Ext
+33
Email
pmllorca@chu-clermontferrand.fr
Facility Name
Service Hospitalo-Universitaire d'Addictologie CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit TROJAK, PHD
Phone
(0)380293769
Ext
+33
Email
benoit.trojak@chu-dijon.fr
Facility Name
CHU Pôle de Psychiatrie Neurologie et Rééducation
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mircea POLOSAN, PHD
Phone
(0)476765383
Ext
+33
Email
mpolosan@chu-grenoble.fr
Facility Name
CH Saint-Cyr-au-Mont-d'Or service de psychiatrie
City
Saint-Cyr-au-Mont-d'Or
ZIP/Postal Code
69450
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian LE CAMUS, MD
Phone
(0)472421183
Ext
+33
Email
flecamus@ch-st-cyr69.fr
Facility Name
CHU de Saint-Etienne
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélia GAY, MD
Facility Name
Centre Hospitalier Alpes Isère
City
Saint-Égrève
ZIP/Postal Code
38120
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément DONDE, MD
Phone
(0)476564340
Ext
+33
Email
cdonde@ch-alpes-isere.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

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