SchizophreniatCCSNCT05784961
Impact of tDCS on Cannabis Craving in Schizophrenia
A study testing tDCS in people with Schizophrenia and Cannabis Use Disorder, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
Trial summary
This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Cannabis Use Disorder
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2024to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.).
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- Subjects already treated by tDCS
- Patients under legal guardianship (except under curatorship)
- Patients under safeguard of justice
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Ch Ville Evrard
Neuilly-sur-Marne, 93330
Dominique Januel, MBBS
Youcef Bencherif
Neuilly-sur-Marne, 93330
Youcef BENCHERIF, 0782723674, bencherif.info@gmail.com
About this study
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
This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.
Read the 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.
- Conditions
- Schizophrenia, Cannabis Use Disorder
- Being tested
- tDCS
- Keywords
- cannabis use disorder, schizophrenia, cannabis, craving
- Medical subject headings
- Schizophrenia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial direct current stimulation (active tDCS) | Experimental | 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) Receives: Device: tDCS |
| Sham tDCS | Placebo comparator | 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 Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marijuana Craving Questionnaire (MCQ)
To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63.
Measured: At baseline (Visit 2) and Day 5 (Visit 6)
Secondary outcomes (12)
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.
Measured: At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
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).
Measured: At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Change in Score of CGI (Clinical Global Impression) to clinical outcome
CGI scale assess clinical outcome
Measured: At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
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.
Measured: 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)
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.
Measured: 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)
Change in BART Analogue Risk Task score
BART Analogue Risk assesses risk taking behavior
Measured: At baseline (Visit 2) and Day 5 (V6)
change in STROOP Test score
Stroop test assesses continuous attention and inhibition abilities
Measured: At baseline (Visit 2) and Day 5 (V6)
Change in Exhaled carbon monoxide concentration score
concentration assessment of monoxide de concentration
Measured: At baseline (Visit 2) and Day 5 (V6)
Urinary cannabis test
assessemnt of cannabis presence in urine
Measured: between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Cannabis and tobacco use assessement
Assessment of actual use of cannabis and tobacco (numbers of cigarettes, number of joints
Measured: At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)
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).
Measured: Baseline (Visit 2)
Change in MCQ (Marijuana Craving Questionnaire)
The minimum value is 9 and the maximum value is 63.
Measured: At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- tDCS versus sham tDCS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noomane Bouaziz, MD, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784961
- Sponsor's protocol ID
- 10477M-tCCS
- Acronym
- tCCS
- Status last verified
- Feb 2024
- First submitted
- 17 Oct 2021
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05784961
- Acronym / sponsor ID
- tCCS / 10477M-tCCS
- Conditions
- Schizophrenia, Cannabis Use Disorder
- Keywords
- cannabis use disorder, schizophrenia, cannabis, craving
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- tDCS versus sham tDCS
| Arm | Type | Receives |
|---|---|---|
| Active transcranial direct current stimulation (active tDCS) | Experimental | Device: tDCSThe 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) |
| Sham tDCS | Placebo comparator | Device: tDCSSham 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCStDCS 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. | Device | Active transcranial direct current stimulation (active tDCS), Sham tDCS |
Primary outcome
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.
12 secondary outcomes
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)
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)
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)
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)
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)
Change in BART Analogue Risk Task score
Time frame: At baseline (Visit 2) and Day 5 (V6)
change in STROOP Test score
Time frame: At baseline (Visit 2) and Day 5 (V6)
Change in Exhaled carbon monoxide concentration score
Time frame: At baseline (Visit 2) and Day 5 (V6)
Urinary cannabis test
Time frame: between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
Cannabis and tobacco use assessement
Time frame: At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)
Score to Big Five to assessed the personnality dimensions
Time frame: Baseline (Visit 2)
Change in MCQ (Marijuana Craving Questionnaire)
Time frame: At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Schizophrenia and Cannabis Use Disorder, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BOUAZIZ Noomane, MD (01 43 09 32 32, urcve@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Marijuana Craving Questionnaire (MCQ) (time frame: At baseline (Visit 2) and Day 5 (Visit 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.