Cortical Excitability and Role of rTMS in Cannabis Use Di... | NCT04106336

Studies
Cortical Excitability and Role of rTMS in Cannabis Use Disorder

NCT04106336

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 27, 2019Actual

Enrollment

60Estimated

Phase

Early Phase 1

Conditions

Cannabis Use Disorder, Moderate

Interventions

rTMS

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Estimated

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Sep 23, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2019

Last Update Posted Date

Sep 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non cannabis addict	No Intervention	30 non cannabis addict will be control group
cannabis addict	Active Comparator	30 cannabis addict will undergo rTMS	Device: rTMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS	Device	Repetitive transcranial magnetic stimulation (rTMS) will be done for cannabis addict	cannabis addict

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of role of rTMS for reducing cannabis craving	Incidenc of cannabis craving after rTMS	1 year

Secondary Outcomes

Measure	Description	Time Frame
Estimation of cortical excitability in cannabis addict	Incidence of cannabis craving after cortical excitability	1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided