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Assessing Executive Function and Drug Craving Modulatory Effects of Transcranial Direct Current Stimulation (tDCS) among Opioid Dependents

Protocol summary

Study aim
Quantitative determination of opium cravings in opioid addicts and the effect of tDCS on it. Quantitative determination of executive dysfunction (decision making, response control and working memory) in opioid addicts and evaluation of the effect of tDCS on it. Determination of changes in serum BDNF levels as a result of treatment with tDCS. Determining the effectiveness of a treatment protocol.
Design
In this study, 72 people are randomly divided into two groups: Real and Sham. The rand function in c++ was used to obtain random numbers and randomization.
Settings and conduct
This study is performed in MMT centers in Tehran. Executive function tests, craving assessment, and serum level BDNF evaluation are performed before and immediately after the intervention, and the tests are repeated 8 weeks later (except BDNF). Participants and statistics analysts are blind, and the method of opaque, sealed envelopes was used.
Participants/Inclusion and exclusion criteria
Opioid users over the age of 18 will be the most benefited from this treatment so they will be included in the study, and those who have contraindications to tDCS, including those with any type of metal plate in the head and brain injury, chronic skin disorders, severe reactions to tDCS in previous treatments, and a history of seizures, will be the most harmed so they will be excluded from the study.
Intervention groups
tDCS is performed for 2 sessions every day for 5 consecutive days. In the Real group, stimulation is performed twice for 13 minutes and at a distance of 10 minutes, 2 mA. In the sham group, the applied electric current will be disconnected after 30 seconds.
Main outcome variables
Craving; Serum level BDNF; Response Inhibition; Working Memory; Decision Making and Risk-Taking

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200927048850N1
Registration date: 2020-10-10, 1399/07/19
Registration timing: prospective

Last update: 2020-10-10, 1399/07/19
Update count: 0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Roghieh Bahareh Borzooee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 8364
Email address
b.borzooee@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing Executive Function and Drug Craving Modulatory Effects of Transcranial Direct Current Stimulation (tDCS) among Opioid Dependents
Public title
Assessing the effect of tDCS on opioid addicts and their brain function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects have to be male Subject who is right-handed Subject whose age is between 18 to 55 years At least the fifth elementary education Have opioid dependence criteria based on DSM-5 criteria Have no other psychiatric or neurological illness The main substance consumption have to be opium Do not consume other substances during the project Subject consents to participation in the study and provides a signed informed consent form
Exclusion criteria:
Contraindications to tDCS include the presence of any type of cerebral injury in the brain and metal plates on the head, chronic skin problems, severe reactions to tDCS in previous treatments, history of seizures
Age
From 18 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The blocking method is used for randomization in this study. In this method, at first, the block size is determined. Considering the possible loss to follow-up, the sample size is considered to be 72, and considering that we have two groups (R (Real) and (S) Sham, the block size is considered to be 4, and then the list of blocks is written (SRRS). , (SRSR), (SSRR), (RSSR), (RSRS), (RRSS). By writing a program in ٌC ++ language, we create random numbers (numbers between 0 and 51 are considered to be R and numbers between 51 and 100 are considered to be S) and finally we determined the blocks based on the assigned random numbers. We ask the participants to choose a number from 0 to 6. Because we have 6 blocks, we can have 12 people in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, data analyst and participants are kept blind to the allocation of study groups. After randomization, the opaque sealed envelope method is used. Researchers and project implementers are not blind to the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
In this study, changes in serum BDNF levels are also evaluated.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Haftom-e Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SHMU.REC.1397.222

Health conditions studied

1

Description of health condition studied
Drug use disorder
ICD-10 code
F11.188
ICD-10 code description
Opioid abuse with other opioid-induced disorder

Primary outcomes

1

Description
Rate of changes in baseline substance craving and cue-induced craving
Timepoint
Before the intervention and after the intervention (fifth day) and 2 months later
Method of measurement
Visual Analog Scale, Desire for Drug Questionnaire, Obsessive-Compulsive Drug Use Scale

2

Description
serum level changes of Brain-Derived Neurotrophic Factor
Timepoint
Before the intervention and after the intervention (fifth day)
Method of measurement
Enzyme-Linked Immunosorbent Assay(ELISA)

3

Description
Evaluation of changes in short-term memory and working memory
Timepoint
Before the intervention and after the intervention (fifth day) and 2 months later
Method of measurement
Forward & Backward Digit span Test

4

Description
Evaluation of changes in response inhibition and impulsivity
Timepoint
Before the intervention and after the intervention (fifth day) and 2 months later
Method of measurement
Go-No Go Test

5

Description
Evaluation of changes in decision making and risk-taking
Timepoint
Before the intervention and after the intervention (fifth day) and 2 months later
Method of measurement
Balloon Analog Risk Task (BART)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Transcranial Direct Current Stimulation (tDCS) is performed 2 times a day for 5 consecutive days. Stimulation is performed twice in the intervention group for 13 minutes and with 10 minutes interval, 2 mA.
Category
Treatment - Other

2

Description
Control group: In this group, Transcranial Direct Current Stimulation (tDCS) at 2 mA is cut off after 30 seconds. This protocol is performed for 5 consecutive days, 2 sessions every day and 13 minutes each session with 10 minutes interval.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Saye Clinic
Full name of responsible person
Milad Taksibi
Street address
Unit7, No 15, Etemadian St, Ayatolah Kashani Blvd
City
Tehran
Province
Tehran
Postal code
1481798364
Phone
+98 21 4496 4355
Email
milad_taksibi@yahoo.com

2

Recruitment center
Name of recruitment center
Behjo Clinic
Full name of responsible person
Dr. Peyman Hasani Abharian
Street address
Unit 44, No 242, Afra Bild, East Ferdos Blvd
City
Tehran
Province
Tehran
Postal code
1481737449
Phone
+98 21 4407 6066
Email
Abharian1972@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Haftom-e Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
emamian@shmu.ac.ir
Web page address
http://shmu.ac.ir
Grant name
Vice Chancellery of Research and Technology
Grant code / Reference number
97135
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Roghieh Bahareh Borzooee
Position
PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Addiction Studies
Street address
Haftom-e Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
b.borzooee@shmu.ac.ir
Web page address
http://shmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahrokh Aghayan
Position
Vice Chancellor for Cultural and Student Affairs- University faculty member
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Haftom-e Tir square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
aghayan@shmu.ac.ir
Web page address
http://shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Roghieh Bahareh Borzooee
Position
PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Addiction Studies
Street address
Haftom-e Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
b.borzooee@shmu.ac.ir
Web page address
http://shmu.ac.ir

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
All personal data of the participants are shared without a name and personal information (unidentifiable).
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of all data or documents for researchers for use in scientific research with reference to the source is allowed.
From where data/document is obtainable
To the researcher of this study, Roghieh Bahareh Borzooee, refer to the email address b.borzooee@shmu.ac.ir
What processes are involved for a request to access data/document
By sending an email to b.borzooee@shmu.ac.ir, the files will be provided to the applicant within 15 days.
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