Evaluation the effectiveness of direct electrical brain stimulation (tDCS) on cognitive functions and cravings in drug addicts undergoing maintenance treatment
The effectiveness of direct electrical brain stimulation (tDCS) on cognitive functions and cravings in drug addicts undergoing maintenance treatment
Design
Clinical trial with control group, with parallel groups, non blind, randomized, on 30 patients
Settings and conduct
Place of study: Navid drug addiction treatment clinic located in Semnan city; Study population: all substance dependent people treated with methadone maintenance drug in Semnan city; Type of blinding: Blinding was not done in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent, having at least elementary education, not using drugs (narcotics), using maintenance treatment method. Exclusion criteris: using methods other than maintenance methods to treat addiction, female gender, illiteracy.
Intervention groups
Intervention group: direct electrical brain stimulation (tDCS).
Control group: usual treatment program without any intervention or change.
Main outcome variables
Cognitive function, cravings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230816059170N1
Registration date:2023-12-20, 1402/09/29
Registration timing:retrospective
Last update:2023-12-20, 1402/09/29
Update count:0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
mostafa nikfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3336 0529
Email address
nikfardmostafa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-03, 1402/04/12
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
2023-07-03, 1402/04/12
Actual recruitment end date
2023-09-11, 1402/06/20
Trial completion date
2023-09-21, 1402/06/30
Scientific title
Evaluation the effectiveness of direct electrical brain stimulation (tDCS) on cognitive functions and cravings in drug addicts undergoing maintenance treatment
Public title
The effectiveness of direct electrical stimulation of the brain on cognitive functions and craving
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the research
Having at least primary education
No drug use
Use of maintenance treatment method
Exclusion criteria:
Using a method other than conservative treatment methods
female gender
Illiteracy
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate people in the study groups, the dice throwing method was used so that the numbers 1, 2, and 3 were defined for the placement of people in the tDCS treatment group, and the numbers 4, 5, and 6 were defined for the placement of people in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan Azad University
Street address
No 44; Yas building; Sizdahom Gharbi street; Taavon town
City
Semnan
Province
Semnan
Postal code
3514753367
Approval date
2023-07-18, 1402/04/27
Ethics committee reference number
IR.IAU.SEMNAN.REC.1402.052
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F11
ICD-10 code description
Opioid related disorders
Primary outcomes
1
Description
Craving
Timepoint
Before starting the intervention and after 10 treatment sessions
Method of measurement
Craving questionnaire
2
Description
Cognitive function
Timepoint
Before starting the intervention and after 10 treatment sessions
Method of measurement
Working memory performance questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received ten sessions of transcranial electric current stimulation. Intervention with OASIS PRO WITH tDCS device from MIND ALIVE company was used. Subjects in this group participated in treatment sessions every other day for ten sessions. Anode electrode was placed in the posterolateral region of the left prefrontal cortex and cathode electrode was placed in the posterolateral region of the right prefrontal cortex, and in each session for 20 minutes, a current of 2 milliamps of direct electric current was passed through the skull of the subjects.
Category
Treatment - Devices
2
Description
Control group: The control group continued their usual treatment program and did not receive any other intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Navid addiction treatment clinic
Full name of responsible person
Dr. Hajar Kasaian
Street address
3rd floor; Aftab building; Ghaem Blvd.
City
Semnan
Province
Semnan
Postal code
3519667961
Phone
+98 23 3334 6672
Email
dr.hkasaian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezu Tahan
Street address
Semnan Azad University; Sokan Park
City
Semnan
Province
Semnan
Postal code
۳۷۱۱۱-۳۵۱۳۱
Phone
+98 23 3165 6565
Email
info@semnaniau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Semnan branch
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
Islamic Azad University
Full name of responsible person
Mostafa Nikfard
Position
Psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 44; Yas building; Sizdahom Gharbi street; Taavon town
City
Semnan
Province
Semnan
Postal code
3514753367
Phone
+98 23 3336 0529
Fax
Email
nikfardmostafa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mostafa Nikfard
Position
Psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 44; Yas building; Sizdahom Gharbi street; Taavon town
City
Semnan
Province
Semnan
Postal code
3514753367
Phone
+98 23 3336 0529
Fax
Email
nikfardmostafa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mostafa Nikfard
Position
Psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 44; Yas building; Sizdahom Gharbi street; Taavon town
City
Semnan
Province
Semnan
Postal code
3514753367
Phone
+98 23 3336 0529
Fax
Email
nikfardmostafa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Late 2023
To whom data/document is available
It can be made available to the public
Under which criteria data/document could be used
Permission is granted
From where data/document is obtainable
nikfardmostafa@gmail.com
What processes are involved for a request to access data/document
After submitting the application and checking the documents