Investigating the Effect of Cranio-electrical stimulation (CES) on Depression, Anxiety and craving in people who received methadone maintenance treatment
Investigating the Effect of Cranio- Electrical Stimulation on Depression, Anxiety and craving in client with methadone maintenance treatment.
Design
A randomized, double-blind, randomized controlled clinical trial of 60 individuals receiving methadone maintenance treatment
Settings and conduct
The place of intervention and study steps in addiction treatment centers were randomly selected. Thirty people with the device turned on and thirty people with the device turned off are randomly checked by a third person outside the reader. The subjects do not know if the device is on or off. Researchers also do not know which person is in which category.
Participants/Inclusion and exclusion criteria
People on methadone treatment who are at least one month old from the start of methadone treatment, want to participate in the study, have no serious psychiatric problems, do not take psychiatric medication and have no history of head trauma and seizures are included in the study. People who test positive for urine during the study or those who do not want to continue studying are excluded from the study.
Intervention groups
The intervention group includes patients treated with methadone who receive clear device intervention.
The comparison group includes patients treated with methadone who receive silent device intervention.
Main outcome variables
Hamilton Anxiety Score
Hamilton Depression Score
Examine substance craving
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051367N1
Registration date:2022-05-13, 1401/02/23
Registration timing:registered_while_recruiting
Last update:2022-05-13, 1401/02/23
Update count:0
Registration date
2022-05-13, 1401/02/23
Registrant information
Name
Homa Baghaei ravari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
homabaghaeiravari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Cranio-electrical stimulation (CES) on Depression, Anxiety and craving in people who received methadone maintenance treatment
Public title
Investigating the Effect of Cranio-electrical stimulation (CES) on Depression, Anxiety and craving in people who received methadone maintenance treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people with a history of addiction who are being treated with methadone in an addiction treatment center
The first month of starting methadone treatment
Willingness to participate in the study
No serious psychiatric problem
No use of psychiatric drugs
No history of head trauma
Exclusion criteria:
Not Willingness to participate in the study
serious psychiatric problem
No treatment on methadone
History of head truama
Use psychiatric drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant is not aware of whether the device is on or off. Also , the researcher and evaluator aren't awared with the device turned on and which with the device turned off
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research, school of medicine, shahid beheshti university of medical sciences
Street address
next to taleghani hospital, arabi street, yemen street, chamran highway
City
tehran
Province
Tehran
Postal code
1985717434
Approval date
2021-07-13, 1400/04/22
Ethics committee reference number
IR.SBMU.MSP.REC.1400.207
Health conditions studied
1
Description of health condition studied
major depression disorder
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
anxiety disorder
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
assessing the temptation to use drugs in the questionnaire to measure the temptation to use drugs after quitting/Primary consequence
Timepoint
beginning and end of study
Method of measurement
the questionnaire to measure the temptation to use drugs after quitting
Secondary outcomes
1
Description
depression score on the hamilton depression inventory
Timepoint
beginning and end of study
Method of measurement
hamilton depression inventory
2
Description
anxiety score on the hamilton anxiety inventory
Timepoint
beginning and end of study
Method of measurement
hamilton anxiety inventory
Intervention groups
1
Description
Intervention group: being treated with electrical brain stimulation in people receiving methadone maintenance treatment. The ATANG low frequency CES brand brain electrical stimulation device is model AT-9. The clear brain electrical stimulation device is used in the intervention group for eight weeks and three days a week, two sessions a day and each session for 30 minutes
Category
Treatment - Devices
2
Description
Control group: Silent electrical brain stimulation device is used in the control group for eight weeks and three days a week, two sessions a day and each session for 30 minutes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Ali kheradmand
Street address
Next to Shahid beheshti medical university, Shahid arabi street, Yemen street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. afshin zarghi
Street address
fifth floor, sructure 2, shahid arabi st. , yemen st. , chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
homa baghaei ravari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
next to shahid beheshti medical university, shahid arabi st. ,yemen st. ,chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 4443 2560
Fax
+98 21 2243 2570
Email
homabaghaeiravari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
homa baghaei ravari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Taleghani hospital, next to shahid beheshti medical university, shahid arabi st. , yemen st. , chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
homabaghaeiravari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
homa baghaei ravari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
next to shahid beheshti medical university, shahid arabi st. , yemen st. , chamran highway, Taleghani hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
homabaghaeiravari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
client's data is accessible with the exception of personal information
When the data will become available and for how long
access period starts six months after the results are published
To whom data/document is available
can be used for adiction treatment centers, psychiatrists and medical engineering researchers
Under which criteria data/document could be used
to use a cranio-electerical stimulation device in psychiatric studies
From where data/document is obtainable
homabaghaeiravri@gmail.com
What processes are involved for a request to access data/document
send a message to the mentioned email or call 00989120220737