Cortical Excitability and Role of rTMS in Cannabis Use Disorder

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04106336
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 15

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cannabis Use Disorder, Moderate	Device: rTMS	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cortical Excitability and Role of rTMS in Cannabis Use Disorder
• Anticipated Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Oct 1, 2020
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

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	Device: rTMS; Repetitive transcranial magnetic stimulation (rTMS) will be done for cannabis addict

Outcome Measures

Primary Outcome Measures

1. Determination of role of rTMS for reducing cannabis craving [1 year]

   Incidenc of cannabis craving after rTMS

Secondary Outcome Measures

1. Estimation of cortical excitability in cannabis addict [1 year]

   Incidence of cannabis craving after cortical excitability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asmaa Omar Radwan Helal, Asmaa Omar Radwan Helal, Assiut University
• ClinicalTrials.gov Identifier: NCT04106336
• Other Study ID Numbers: rTMS in cannabis use disorder
• First Posted: Sep 27, 2019
• Last Update Posted: Sep 27, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Marijuana Abuse

Study Results

No Results Posted as of Sep 27, 2019