Cortical Excitability and Role of rTMS in Cannabis Use Disorder

September 25, 2019 updated by: Asmaa Omar Radwan Helal, Assiut University
Repetitive transcranial magnetic stimulation (rTMS) and cortical excitability have a role in cannabis use disorder

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: non cannabis addict
30 non cannabis addict will be control group
Active Comparator: cannabis addict
30 cannabis addict will undergo rTMS
Repetitive transcranial magnetic stimulation (rTMS) will be done for cannabis addict

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • rTMS in cannabis use disorder

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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