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

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

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Repetitive Transcranial Magnetic Stimulation Device: Repetitive Transcranial Magnetic Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Substance Misuse To Psychiatric Disorders-Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Arm 1
Subjects receive 20 rTMS sessions in 2 weeks
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.

Active Comparator: Arm 2
Subjects receive 20 rTMS sessions in 4 weeks
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.

Active Comparator: Arm 3
Subjects receive 20 rTMS sessions in 5 weeks
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05292547


Contacts
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Contact: Albert KK Chung, MBBS +85260440993 Chungkka@hku.hk
Contact: Jackal Tse, MSc 0085260440993 Jackal21@hku.hk

Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, 000000
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Albert KK Chung, MBBS Department of Psychiatry, The University of Hong Kong
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT05292547    
Other Study ID Numbers: UW21-656
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
Cannabis
TMS
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders