This study aimed at assessing the effect of repeated magnetic stimulus
from skull (rTMS) on decrease of desire of drug abuse in addicts to metamphetamine (MA).
Design
Clinical trial with control group, with parallel groups, without blinding, randomized on 50 patients and randomized by simple method (envelope) was performed.
Settings and conduct
This research is carried out in four stages in 22 Bahman Hospital in Qazvin; Step 1: Interview and evaluate the subjects before the experiment. Step 2: Apply therapeutic intervention. Step 3: Evaluate the effectiveness of the intervention. Stage 4: Evaluation of the duration of the therapeutic effect after one and a half months.
Participants/Inclusion and exclusion criteria
The statistical sample of this study includes 50 patients (men) who referred to 22 Bahman Hospital in Qazvin in 1397 and have a medical record. The condition of the patients is such that if the urine test is negative at the beginning of treatment and during the treatment, also the craving score of the subjects is more than 28 according to self-report, none of the patients is in a state of restlessness. Consumption of MA.
Intervention groups
Intervention group: In the treatment position, which is in the form of receiving transcranial electrical stimulation, which is done in the form of 20 sessions of therapy for 4 weeks and each time for 30 minutes. Then the questionnaire for assessing the craving for substances is completed by the questioner.
In the control group of patients without receiving transcranial electrical stimulation, the first day of the study, 7 days later and 45 days later are completed by the questioner 3 times, respectively.
Main outcome variables
drug use craving, addictive behaviors
General information
Reason for update
Acronym
TMS
IRCT registration information
IRCT registration number:IRCT20180317039114N1
Registration date:2021-03-01, 1399/12/11
Registration timing:retrospective
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Islamic republic of iran Batebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 1247
Email address
r.batebi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-13, 1397/04/22
Expected recruitment end date
2018-10-14, 1397/07/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate The Effect of Transcranial Magnetic Stimulation (TMS) on craving in Patients with Methamphetamine Use Disorder.
Public title
The effect of Transcranial Magnetic Stimulation in patients with Methamphetamine Use Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men aged 20 to 50 years
craving score of 28 or more on methamphetamine
having a negative urine test at the beginning and duration of the study
no history of counseling and psychotherapy during this period.
Exclusion criteria:
history of concussion or seizures in the person
history of bipolar disorder or severe psychological symptoms
use of other psychotropic substances
severe physical illness
lack of metal, prosthesis, shunt in the skull
no heartbeat
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, Individual, Sealed Envelope Randomization
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
National Ethics Committee on Qazvin Biomedical Research
Street address
pastor street,22bahman hospital.
City
Qazvin
Province
Qazvin
Postal code
3416899198
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.QUMS.REC.1397.373
Health conditions studied
1
Description of health condition studied
Patients' obsession with methamphetamine
ICD-10 code
R46.81
ICD-10 code description
Obsessive-compulsive behavior
Primary outcomes
1
Description
Methamphetamine temptation score in Desires for Drug Questionnaire
Timepoint
Before the intervention, 7, 45 days after the start
Method of measurement
Desires for Drug Questionnaire (DDQ questionnaire)
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before the intervention, 7.45 days later
Method of measurement
Criteria for the Fifth Diagnostic and Statistical Guidelines for Mental Disorders
Intervention groups
1
Description
Intervention group: In the treatment position, in the form of receiving transcranial electrical stimulation, which is performed in the form of 20 sessions of therapy for 4 weeks and each time for 30 minutes. Questionnaire to assess the craving for substances is completed by the questioner.
Category
Treatment - Devices
2
Description
Control group: In the placebo position, which is completed by the questioner on the first day of the study, 7 days later and 45 days later, respectively, without receiving transcranial electrical stimulation.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital in Qazvin
Full name of responsible person
Reza Batebi
Street address
22 Bahman Hospital,Parstar ,Railway Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3355 0188
Fax
Email
hospital.bahman@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reza Batebi
Street address
Parstar Alley,Railway Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3355 0188
Email
r.batebi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Reza Batebi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Parstar Alley, Railway Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3355 0188
Email
r.batebi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reza Batebi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Parstar Alley, Railway Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3355 0188
Email
r.batebi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reza Batebi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Parstar Alley, Railway Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3355 0188
Email
r.batebi@qums.ac.ir
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