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

• ClinicalTrials.gov Identifier: NCT05292547
• Recruitment Status: Not yet recruiting
• First Posted: March 23, 2022
• Last Update Posted: March 23, 2022
• Sponsor: The University of Hong Kong
• Information provided by (Responsible Party): The University of Hong Kong

Tracking Information

• First Submitted Date: March 13, 2022
• First Posted Date: March 23, 2022
• Last Update Posted Date: March 23, 2022
• Estimated Study Start Date: September 1, 2022
• Estimated Primary Completion Date: January 1, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 22, 2022)

• A change in amount of cannabis use [ Time Frame: 12 months ]
  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
• A change in frequency of Cannabis Use [ Time Frame: 12 months ]
  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
• Severity of Cannabis Use Disorder [ Time Frame: 12 months ]
  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
• Severity of Dependence [ Time Frame: 12 months ]
  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
• Craving [ Time Frame: 12 months ]
  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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 22, 2022)

• Level of Anxiety [ Time Frame: 12 months ]
  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
• Level of Depression [ Time Frame: 12 months ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder (SToP-C-rTMS x CUD)
• Official Title: Substance Misuse To Psychiatric Disorders-Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder

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:

1. Multiple rTMS sessions can reduce craving for cannabis, severity of CUD, frequency and amount of cannabis use.
2. Different rTMS treatment schedules have differences in reducing the craving for cannabis and severity of CUD, and prolonging relapse of cannabis use.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cannabis Use Disorder
• Repetitive Transcranial Magnetic Stimulation

Intervention

Device: Repetitive Transcranial Magnetic Stimulation

rTMS using Magventure TMS system is delivered at the dorsolateral prefrontal cortex of consented subjects according to 3 different stimulation schedules.

Study Arms

• Active Comparator: Arm 1
  Subjects receive 20 rTMS sessions in 2 weeks
  Intervention: Device: Repetitive Transcranial Magnetic Stimulation
• Active Comparator: Arm 2
  Subjects receive 20 rTMS sessions in 4 weeks
  Intervention: Device: Repetitive Transcranial Magnetic Stimulation
• Active Comparator: Arm 3
  Subjects receive 20 rTMS sessions in 5 weeks
  Intervention: Device: Repetitive Transcranial Magnetic Stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 22, 2022): 18
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2026
• Estimated Primary Completion Date: January 1, 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Albert KK Chung, MBBS; +85260440993; Chungkka@hku.hk

Contact: Jackal Tse, MSc; 0085260440993; Jackal21@hku.hk

• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT05292547
• Other Study ID Numbers: UW21-656
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: The University of Hong Kong
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Hong Kong
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Albert KK Chung, MBBS; Department of Psychiatry, The University of Hong Kong

• PRS Account: The University of Hong Kong
• Verification Date: March 2022