tCCS: Impact of tDCS on Cannabis Craving in Schizophrenia

Sponsor

Centre hospitalier de Ville-Evrard, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05784961

Collaborator

(none)

138

Enrollment

Locations

Arms

48.4

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Cannabis Use Disorder	Device: tDCS	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

tDCS versus sham tDCStDCS versus sham tDCS

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 8, 2021

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Apr 20, 2025

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Change in Marijuana Craving Questionnaire (MCQ) [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 Outcome Measures

Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia [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.
Change in Score of SNS (schizophrenia negative symptoms) to assess negative symptoms [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).
Change in Score of CGI (Clinical Global Impression) to clinical outcome [At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)]
CGI scale assess clinical outcome
Change in VAS score (visual analog scale) to assess the craving to cannabis [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.
Change in VAS score (visual analog scale) to assessed the craving to nicotine [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.
Change in BART Analogue Risk Task score [At baseline (Visit 2) and Day 5 (V6)]
BART Analogue Risk assesses risk taking behavior
change in STROOP Test score [At baseline (Visit 2) and Day 5 (V6)]
Stroop test assesses continuous attention and inhibition abilities
Change in Exhaled carbon monoxide concentration score [At baseline (Visit 2) and Day 5 (V6)]
concentration assessment of monoxide de concentration
Urinary cannabis test [between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)]
assessemnt of cannabis presence in urine
Cannabis and tobacco use assessement [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
Score to Big Five to assessed the personnality dimensions [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).
Change in MCQ (Marijuana Craving Questionnaire) [At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)]
The minimum value is 9 and the maximum value is 63.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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