The purpose of this research is to determine the effectiveness of transcranial electrical stimulation in reducing drug craving and impulsivity in methamphetamine use disorder.
Design
Study groups include intervention and control groups. The intervention group will receive brain electrical stimulation and the control group will receive sham or placebo electrical stimulation, and the type of randomization of patients in two randomization groups is blocked. The sample size for each group includes 10 people.
Settings and conduct
Using a simple randomization method, clients are divided into two intervention groups: real electrical stimulation and sham electrical stimulation. The intervention will be in the form of 10 sessions of electrical brain stimulation and every other day (three days a week, for 4 weeks). The intensity of the current is 2 milliamps, the size of the electrodes is 7x5, and according to the 10-20 EEG division system, the location of the anode electrode will be in the F4 region (right DLPFC) and the cathode electrode will be in the F3 region (left DLPFC).
according to the type of study, in the first, fifth, tenth and two weeks after the completion of the relevant evaluations will be done by a specialist doctor;
Participants/Inclusion and exclusion criteria
In this study, 24 people with methamphetamine use disorder after completing the acute phase and being discharged from Ibn Sina Psychiatric Hospital were selected as available sampling and referred to the Center for Psychiatry and Behavioral Sciences of Ibn Sina Hospital.
Craving
impulsiveness
Positive and negative emotions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221001056065N3
Registration date:2024-09-21, 1403/06/31
Registration timing:registered_while_recruiting
Last update:2024-09-21, 1403/06/31
Update count:0
Registration date
2024-09-21, 1403/06/31
Registrant information
Name
Maedeh Kamrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3700 2202
Email address
kamranim@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2025-07-22, 1404/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of transcranial electrical stimulation in preventing relapse in methamphetamine addicts
Public title
Investigating the effectiveness of transcranial electrical stimulation in methamphetamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Getting out of the acute phase of the disease and detoxification caused by methamphetamine consumption after at least one week of hospitalization and discharge from the hospital.
2. Lack of previous participation in transcranial electrical stimulation treatment.
3. Diagnosis of methamphetamine use disorder based on DSM5.
4. Abstaining from any illegal substance other than smoking for at least 72 hours prior to the test, as confirmed by the urine test kit.
Exclusion criteria:
1. Current or past major clinical neurological disorder.
2. History of epilepsy, brain surgery, tumor, intracranial metal implantation.
3. Clinically significant head injury.
4. Any major clinical psychiatric disorder other than substance-related disorders caused by methamphetamine use.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization guarantees that there is no significant imbalance between the groups during randomization, and at certain points the number of participants in each group is equal. For this method, the size of each block must be determined first example block of four). Then write the list of blocks and assign numbers to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) then choose random numbers between 1 and 6 (for example, 1, 4, 5, etc.) and finally specifying the treatment allocation list based on the previous random numbers (AABB-BBAA-BABA-).}
Blinding (investigator's opinion)
Single blinded
Blinding description
single blind
In this type of blinding, the patient is not aware of the type of intervention and does not know whether he is in the intervention group or the control group. Of course, according to the randomization method, the researcher knows which group the patient is in and adjusts the device according to the group the patient is in. Therefore, the participants know that they are being treated; But they are not aware of which group they are in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Razavi Khorasan Province, Mashhad, Horr Ameli Blvd. Psychiatry and Behavioral Sciences Research Center
City
mashhad
Province
Razavi Khorasan
Postal code
05137112540
Approval date
2024-09-22, 1403/07/01
Ethics committee reference number
IR.MUMS.REC.1403.218
Health conditions studied
1
Description of health condition studied
stimulant dependence
ICD-10 code
F15.2
ICD-10 code description
Other stimulant dependence
Primary outcomes
1
Description
craving
Timepoint
First. The middle and end of the study
Method of measurement
Questionnaire
Secondary outcomes
1
Description
impulsivity
Timepoint
First. the middle end of study
Method of measurement
Barrett impulsivity questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: transcranial electrical stimulation in F3 and F4 areas.
Category
Diagnosis
2
Description
Control group: Sham electrical stimulation in F3 and F4 areas
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان فوق تخصصی روانپزشکی ابن سینا
Full name of responsible person
dr Maedeh kamrani
Street address
Horr Ameli Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2701
Fax
+98 51 3711 2701
Email
kamranim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Mashhad, University Street, Beside Hoveyzeh Cinema, Qurashi Building, Research and Technology Vice, Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3843 0249
Fax
+98 51 3711 2701
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Maedeh Kamrani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Horr Ameli Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2701
Email
kamranim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maedeh Kamrani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebn e sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3700 2202
Fax
Email
kamranim@mums.ac.irt
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maedeh Kamrani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebn e sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3700 2202
Fax
Email
kamranim@mums.ac.irt
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
En After completing the study and obtaining permission from the Research Vice-Chancellor of Mashhad University of Medical Sciences, the researchers are ready to publish the results of the study in the form of an article.
When the data will become available and for how long
Access to the data will be without time limit and will be present in the published results.
To whom data/document is available
After the completion of the project (about one year after starting the work) and the resident's defense of his/her thesis, the researchers are ready to publish the results.
Under which criteria data/document could be used
Officials of Mashhad University of Medical Sciences and, therapists working in the field of mental health
From where data/document is obtainable
Mashhad University of Medical Sciences, Research department
What processes are involved for a request to access data/document
Refer to research unit of Mashhad Medical Sciences Faculty, Dissertations Unit and obtain access permission