Investigating the effect of transcranial Direct Current Stimulation (tDCS) on reducing the craving and preventing the recurrence of taking methamphetamine on patients referred to the addiction treatment clinic
Design
Qualified patients will be randomly divided into two real tDCS and fake tDCS groups. Accidental randomization will be performed based on random numbers. This clinical trial has a community-based, action-oriented control group with parallel and one-way blind groups.
Settings and conduct
Qualified patients will be randomly divided into two real tDCS and fake tDCS groups. Accidental randomization will be performed based on random numbers table. This clinical trial has a community-based, action-oriented control group with parallel and one-way blind groups.
Participants/Inclusion and exclusion criteria
Including criteria: aged over 18 years old; methamphetamine addiction based on DSM-V classification criteria for psychiatric and behavioral disorders; sustained clinical symptoms.
Exclusion criteria: any neurological major or recent major effects; central system effects of drug use; history of epilepsy; brain surgery; tumor; intracranial metallic implants.
Intervention groups
Qualified patients based on DSM-V criteria for methamphetamine addiction will be randomly divided into two groups of tDCS and fictitious tDCS if they are eligible for inclusion in the study.
Intervention group: The true tDCS group will receive 2 sessions of right anode and left cathode stimulation sessions by an experienced technician with no knowledge of the subject and an interventional therapist randomly for 20 minutes and 2 mA on the lateral posterior frontal area.
Control group: The tDCS group will receive 2 mAh for 1 minute and will not receive a stream in the next 19 minutes.
Main outcome variables
The rate of craving for methamphetamine
General information
Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT20181117041682N1
Registration date:2018-11-29, 1397/09/08
Registration timing:prospective
Last update:2018-11-29, 1397/09/08
Update count:0
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Ahmad Fakhri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3622 4558
Email address
ahmad_fakhri@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcranial direct current stimulation (tDCS) on decreasing craving and preventing recurrence of methamphetamine users
Public title
The effect of transcranial direct current stimulation on decreasing craving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years old
Methamphetamine addiction based on the DSM-V classification criteria for mental and behavioral disorders
Sustained clinical symptoms
Ability to read and write
Exclusion criteria:
Has any neurological major or recent major neurological disorder
The effects of the central system of drug use
History of epilepsy, brain surgery, tumor, intracerebral metal implant, symptomatic head trauma or any major psychiatric disorder
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a random number table will be used. In this table, random numbers do not follow any obvious patterns for randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
An expert technician with no knowledge of the subject and an electric stimulator
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd, Ahvaz, Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.AJUMS.REC.1397.566
Health conditions studied
1
Description of health condition studied
Drug abuse
ICD-10 code
Z71.51
ICD-10 code description
Drug abuse counseling and surveillance of drug abuser
Primary outcomes
1
Description
Determine the amount of craving
Timepoint
Before and after intervention
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The true tDCS group will receive 2 sessions of right anode and left cathode stimulation sessions by an experienced technician with no knowledge of the subject and an interventional therapist randomly for 20 minutes and 2 mA on the lateral posterior frontal area.
Category
Treatment - Other
2
Description
Control group: The tDCS fake group will receive 2 mAh for 1 minute and will not receive a stream in the next 19 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Ahmad Fakhri
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
ahmad_fakhri@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
badavi.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Fakhri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Dr.fakhri@gmil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naeim Sharifat
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Amdap411@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naeim Sharifat
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Amdap411@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available