NCT04106336

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 23, 2019

Last Update Submit

September 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determination of role of rTMS for reducing cannabis craving

    Incidenc of cannabis craving after rTMS

    1 year

Secondary Outcomes (1)

  • Estimation of cortical excitability in cannabis addict

    1 year

Study Arms (2)

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

rTMSDEVICE

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

cannabis addict

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asmaa Omar Radwan Helal

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 27, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

December 30, 2020

Last Updated

September 27, 2019

Record last verified: 2019-09