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NCT Number: NCT05784961

Impact of tDCS on Cannabis Craving in Schizophrenia

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

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Key information

Conditions

Schizophrenia Cannabis Use Disorder Chemically-Induced Disorders Marijuana Abuse Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Ville Evrard, Neuilly-sur-Marne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Marijuana Craving Questionnaire (MCQ)

    Time frame: At baseline (Visit 2) and Day 5 (Visit 6)

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

Secondary outcomes

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

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

    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.

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

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

    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).

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

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

    CGI scale assess clinical outcome

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

    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)

    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.

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

    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)

    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.

  6. Change in BART Analogue Risk Task score

    Time frame: At baseline (Visit 2) and Day 5 (V6)

    BART Analogue Risk assesses risk taking behavior

  7. change in STROOP Test score

    Time frame: At baseline (Visit 2) and Day 5 (V6)

    Stroop test assesses continuous attention and inhibition abilities

  8. Change in Exhaled carbon monoxide concentration score

    Time frame: At baseline (Visit 2) and Day 5 (V6)

    concentration assessment of monoxide de concentration

  9. Urinary cannabis test

    Time frame: between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

    assessemnt of cannabis presence in urine

  10. Cannabis and tobacco use assessement

    Time frame: At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)

    Assessment of actual use of cannabis and tobacco (numbers of cigarettes, number of joints

  11. Score to Big Five to assessed the personnality dimensions

    Time frame: Baseline (Visit 2)

    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).

  12. Change in MCQ (Marijuana Craving Questionnaire)

    Time frame: At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)

    The minimum value is 9 and the maximum value is 63.

Study contacts

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

BENCHERIF Youcef, Project manager

CONTACT

[email protected]

01 43 09 32 32

BOUAZIZ Noomane, MD

CONTACT

[email protected]

01 43 09 32 32

Sponsors and collaborators

Lead sponsor

Centre hospitalier de Ville-Evrard, France

Other

Registry information

Official study title

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

Acronym: tCCS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2023
Registry last updated
Feb 16, 2024

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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