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
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.
Sponsor
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
Additional Relevant MeSH Terms
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.