Impact of tDCS on Cannabis Craving in Schizophrenia

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05784961
• Other study ID #: 10477M-tCCS
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 20, 2027

Study information

• Verified date: February 2024
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: BOUAZIZ Noomane, MD
• Phone: 01 43 09 32 32
• Email: urcve[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: June 20, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients (male or female) aged 18-65

2. Patients with schizophrenia according to DSM 5 criteria with Comorbid diagnosis of "cannabis use disorder"

3. 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

4. Patients without any other drug or psychotherapeutic treatment for cannabis dependence ("naive" patients)

5. Reported cannabis use greater than three times per week in the past three years

6. Signed consent to participate in research

7. Affiliation to a French social security scheme

8. Patient fluent in the French language

Exclusion Criteria:

1. Presence of any other psychiatric disorder, as per DSM-5 criteria.

2. Pregnancy, possible pregnancy due to lack of contraception, breastfeeding.

3. Currently active suicidal or self-injurious ideation (suicidal or not)

4. Patients with Serious medical codition

5. Other "moderate" to "severe" addictions, according to DSM 5 criteria (excluding tobacco and coffee).

6. Contraindications to tDCS (presence of intracranial metal material, intracranial hypertension, etc.).

7. Subjects already treated by tDCS

8. Patients under legal guardianship (except under curatorship)

9. Patients under safeguard of justice

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
France	Youcef Bencherif	Neuilly sur Marne
France	Ch Ville Evrard	Neuilly-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Marijuana Craving Questionnaire (MCQ)	To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63.	At baseline (Visit 2) and Day 5 (Visit 6)
Secondary	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.	At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Secondary	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).	At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Secondary	Change in Score of CGI (Clinical Global Impression) to clinical outcome	CGI scale assess clinical outcome	At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Secondary	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.	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)
Secondary	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.	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)
Secondary	Change in BART Analogue Risk Task score	BART Analogue Risk assesses risk taking behavior	At baseline (Visit 2) and Day 5 (V6)
Secondary	change in STROOP Test score	Stroop test assesses continuous attention and inhibition abilities	At baseline (Visit 2) and Day 5 (V6)
Secondary	Change in Exhaled carbon monoxide concentration score	concentration assessment of monoxide de concentration	At baseline (Visit 2) and Day 5 (V6)
Secondary	Urinary cannabis test	assessemnt of cannabis presence in urine	between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Secondary	Cannabis and tobacco use assessement	Assessment of actual use of cannabis and tobacco (numbers of cigarettes, number of joints	At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)
Secondary	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).	Baseline (Visit 2)
Secondary	Change in MCQ (Marijuana Craving Questionnaire)	The minimum value is 9 and the maximum value is 63.	At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)