Impact of tDCS on Cannabis Craving in Schizophrenia

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia; Cannabis Use Disorder
• Interventions: Device: tDCS

• Registration Number: NCT05784961
• Lead Sponsor: Centre hospitalier de Ville-Evrard, France

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-10-17
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-03-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Study Start: 2024-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	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
Active transcranial direct current stimulation (active tDCS)	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in BART Analogue Risk Task score	At baseline (Visit 2) and Day 5 (V6)	BART Analogue Risk assesses risk taking behavior
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 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
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).
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).
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
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.
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

Trial Locations

Locations (2)

Youcef Bencherif; 🇫🇷 Neuilly sur Marne, France

Ch Ville Evrard; 🇫🇷 Neuilly-sur-Marne, France