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

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05292547
Collaborator
(none)
18
1
3
40
0.4

Study Details

Study Description

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
  • Device: Repetitive Transcranial Magnetic Stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. A change in amount of cannabis use [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong 000000

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05292547
Other Study ID Numbers:
  • UW21-656
First Posted:
Mar 23, 2022
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022