search
Back to results

Cortical Excitability and Role of rTMS in Cannabis Use Disorder

Primary Purpose

Cannabis Use Disorder, Moderate

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
rTMS
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder, Moderate

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18to 50 years of age
  • cannabis use disorder according to DSM 5 definition
  • clear consent to participate in study

Exclusion Criteria:

  • cardiac peacemaker
  • metal implant in the head as participate will be applied to magnetic field of TMS
  • current intake of any medication affect cognition (as anti psychotic and anti epileptic)
  • current history of neurological , psychiatric or general medical disease .current or previous drug (other than cannabis )or alcohol abuse or participation in another trial during the past 8 weeks .
  • age younger than 18 and older than 50 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    non cannabis addict

    cannabis addict

    Arm Description

    30 non cannabis addict will be control group

    30 cannabis addict will undergo rTMS

    Outcomes

    Primary Outcome Measures

    Determination of role of rTMS for reducing cannabis craving
    Incidenc of cannabis craving after rTMS

    Secondary Outcome Measures

    Estimation of cortical excitability in cannabis addict
    Incidence of cannabis craving after cortical excitability

    Full Information

    First Posted
    September 23, 2019
    Last Updated
    September 25, 2019
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04106336
    Brief Title
    Cortical Excitability and Role of rTMS in Cannabis Use Disorder
    Official Title
    Cortical Excitability and Role of rTMS in Cannabis Use Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    October 1, 2020 (Anticipated)
    Study Completion Date
    December 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Repetitive transcranial magnetic stimulation (rTMS) and cortical excitability have a role in cannabis use disorder

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis Use Disorder, Moderate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    non cannabis addict
    Arm Type
    No Intervention
    Arm Description
    30 non cannabis addict will be control group
    Arm Title
    cannabis addict
    Arm Type
    Active Comparator
    Arm Description
    30 cannabis addict will undergo rTMS
    Intervention Type
    Device
    Intervention Name(s)
    rTMS
    Intervention Description
    Repetitive transcranial magnetic stimulation (rTMS) will be done for cannabis addict
    Primary Outcome Measure Information:
    Title
    Determination of role of rTMS for reducing cannabis craving
    Description
    Incidenc of cannabis craving after rTMS
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Estimation of cortical excitability in cannabis addict
    Description
    Incidence of cannabis craving after cortical excitability
    Time Frame
    1 year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18to 50 years of age cannabis use disorder according to DSM 5 definition clear consent to participate in study Exclusion Criteria: cardiac peacemaker metal implant in the head as participate will be applied to magnetic field of TMS current intake of any medication affect cognition (as anti psychotic and anti epileptic) current history of neurological , psychiatric or general medical disease .current or previous drug (other than cannabis )or alcohol abuse or participation in another trial during the past 8 weeks . age younger than 18 and older than 50 years

    12. IPD Sharing Statement

    Learn more about this trial

    Cortical Excitability and Role of rTMS in Cannabis Use Disorder

    We'll reach out to this number within 24 hrs