Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder (SToP-C-rTMS x CUD)

Study Overview
=================
Brief Summary
-----------------
This study is to explore if repetitive transcrinal magnetic stimulation (rTMS) with different stimulation schedules will be equally effective in reducing carving, frequency of cannabis use, and the severity of cannabis use disorder in participants suffering from cannabis use disorder (CUD). The investigators assume the hypotheses as: Multiple rTMS sessions can reduce craving for cannabis, severity of CUD, frequency and amount of cannabis use. Different rTMS treatment schedules have differences in reducing the craving for cannabis and severity of CUD, and prolonging relapse of cannabis use.

Official Title
-----------------
Substance Misuse To Psychiatric Disorders-Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder

Conditions
-----------------
Cannabis Use Disorder, Repetitive Transcranial Magnetic Stimulation

Intervention / Treatment
-----------------
* Device: Repetitive Transcranial Magnetic Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read and communicate in English and/or Chinese SToP-C-rTMS x CUD Able to give informed consent Using cannabis or marijuana as the primary psychoactive substance of abuse Diagnosed with Cannabis Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) by the Structured Clinical Interview for DSM-5 Disorders (SCID-5) Exclusion Criteria: Age <18 years old Unable to read English or Chinese Unable to give informed consent Had been diagnosed with the following disorders, including neurodevelopmental disorders, DSM-5 defined substance use disorder greater than moderate in severity, and neurocognitive disorders Contra-indicated to have rTMS, including subjects with electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator [ICD], cerebral shunts, cochlear implant, etc.), with metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.), pregnant, with any known or history of neurological conditions including cerebral vascular accidents, epilepsy, brain tumor or space occupying lesion, poorly controlled or unstable diabetes mellitus, and receiving unstable dose(s) of antipsychotics, antidepressants, benzodiazepines and/or anticonvulsants in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Subjects receive 20 rTMS sessions in 2 weeks | Device: Repetitive Transcranial Magnetic Stimulation<br>* rTMS using Magventure TMS system is delivered at the dorsolateral prefrontal cortex of consented subjects according to 3 different stimulation schedules.<br>|
| Active Comparator: Arm 2<br>Subjects receive 20 rTMS sessions in 4 weeks | Device: Repetitive Transcranial Magnetic Stimulation<br>* rTMS using Magventure TMS system is delivered at the dorsolateral prefrontal cortex of consented subjects according to 3 different stimulation schedules.<br>|
| Active Comparator: Arm 3<br>Subjects receive 20 rTMS sessions in 5 weeks | Device: Repetitive Transcranial Magnetic Stimulation<br>* rTMS using Magventure TMS system is delivered at the dorsolateral prefrontal cortex of consented subjects according to 3 different stimulation schedules.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in amount of cannabis use | Subject's self-report on the amount of cannabis use (in terms of number of joints per day) at baseline to the amount of use at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS | 12 months | 
| A change in frequency of Cannabis Use | Subject's self-repot on the frequency of cannabis use (in terms of number of times of use per day and/or per week) at baseline to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS | 12 months | 
| Severity of Cannabis Use Disorder | A change in severity of cannabis use disorder measured by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with severity ranges from 0 to 11 (maximum severity) from baseline to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS | 12 months | 
| Severity of Dependence | A change in scorings measured by the Severity of Dependence Scale (ranges from a minimum of 5 to a maximum of 20) from baseline to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS | 12 months | 
| Craving | A change in scorings measured by Marijuana Craving Questionnaire (ranges from a minimum of 17 to a maximum of 119) from baseline to to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Anxiety | A change in severity of anxiety measured by Beck Anxiety Inventory (with a score from a minimum of 0 to a maximum of 63) at baseline to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS | 12 months | 
| Level of Depression | A change in severity of depression measured by Beck Depression Inventory (with a score from a minimum of 0 to a maximum of 63) at baseline to that at at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannabis, TMS