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NCT Number: NCT04871048

Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Le Vinatier Service universitaire d'addictologie de Lyon, Bron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial direct current stimulation (tDCS) active

Device

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.

Transcranial direct current stimulation (tDCS) non active

Device

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 outcomes

  1. cannabis use

    Time frame: 6 months

    Percentage change in cannabis use before and after tDCS treatment

Secondary outcomes

  1. cannabis use

    Time frame: 3 months

    Percentage change in cannabis use before and after 3 months tDCS treatment

  2. Change in craving scores

    Time frame: 3 months and 6 months

    Marijuana Craving Questionnaire score (minimum =12, maximum = 84). The higher the score, the greater the craving.

  3. Hospitalizations

    Time frame: 6 months

    Number of hospitalization(s) during the 6 months after tDCS sessions

  4. Study of structural cerebral connectivity

    Time frame: 3 months

    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

  5. Study of structural and functional cerebral connectivity

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurelia GAY, MD

CONTACT

[email protected]

(0)4 77 82 88 50 ext. +33

Béatrice DEYGAS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Official study title

Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study

Acronym: CANNAPSYSTIM

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
May 4, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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