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

Cannabis Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292547
• Other study ID #: UW21-656
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: July 2023
• Source: The University of Hong Kong
• Contact: Albert KK Chung, MBBS
• Phone: +85260440993
• Email: Chungkka[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse
• 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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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