Evaluation of the therapeutic effect of repetitive Transcranial Magnetic Stimulation (rTMS) on craving in patient with substance dependence
Design
Clinical trial with control group with parallel group, double blinded, randomized
Settings and conduct
Patients with diagnosis of Substance Use Disorder, referred to Shahid Beheshti Hospital, Zanjan in rTMS ward received active or sham stimulation. The patient and researcher do not know the type of stimulation. Only rTMS operator and statistician aware of the type of stimulation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with diagnosis of Substance Use Disorder according to criteria of DSM-5 and absence of multi substance use that do not receive any medicine during the treatment.
Criteria for not entering: The patient be pregnant or have (has) another psychiatric disease, neurological disease (seizure...) or sever physical illness and also presence of metal implants, pacemaker, inner ear prothesis.
Intervention groups
Patient with diagnosis of Substance Use Disorder according to criteria of DSM-5 are divided into two groups of 18 peoples. The intervention group receive real stimulation. The control group receive sham stimulation.
Main outcome variables
Craving in patients with Substance Use Disorder that is measured with the scale of measuring craving for momentary consumption of substance with DDQ (Desire for Drug Questionnaire).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230306057642N1
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Nafiseh Bay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3573 0801
Email address
nafise_bay@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-08, 1402/04/17
Expected recruitment end date
2023-10-09, 1402/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of repetitive Transcranial Magnetic Stimulation (rTMS) on craving in patient with substance dependence
Public title
Evaluation of the therapeutic effect of repetitive Transcranial Magnetic Stimulation (rTMS) on craving in patient with substance dependence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with diagnosis of Substance Use Disorder (SUD) according to criteria of DSM-5
Absence of multi substance use
People should not receive any medicine during the treatment
Exclusion criteria:
Simultaneous diagnosis of every other psychiatric illness according to the criteria of DSM-5
Neurological disease such as seizure, stroke, cerebral vascular disease
Presence of metal implants, pacemaker, inner ear prothesis
Pregnancy
Sever physical illness such as infection, malignancy or unstable medical conditions
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: 36 patients will be selected to participate in the study by being available and passing the admission conditions. But assigning them to each treatment group will be simple randomization. For randomization with the help of Excel software by generating binomial distribution and 50% probability for n=36 we produce codes 0 and 1 . In this way, 18 codes 0 and 18 codes 1 are generated equally. Each participant gets a 0 or 1 code completely randomly and with a 50% probability. Code 0 is considered as the control group and code 1 is considered as the intervention group . In this way, the type of treatment for each person is determined before entering the study and observation by each member of the research team. It should be mentioned that due to the double blinding of the study, only the rTMS operator and statistician know how to code and assign patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind. This means that the researcher and the patient do not know the type of treatment. Due to the fact that the treatment can be performed on the patient by the rTMS operator, the double-blind condition can be applied accurately. It should be mentioned that due to the double blinding of the study, only the rTMS operator and statistician know how to code and assign patients. Patients have already read and signed the informed consent form. All patients are connected to the rTMS device, and the cap of the device is placed on their head. No patient is aware of the type of stimulation (active or sham). The rTMS operator knows the type of stimulation. For patients receiving active stimulation, the device is set to 10 Hz. For patients receiving sham stimulation, the device is set to 0 Hz.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Dr sobooti Blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2022-11-24, 1401/09/03
Ethics committee reference number
IR.ZUMS.REC.1401.235
Health conditions studied
1
Description of health condition studied
Substance Use Disorder
ICD-10 code
F11.2
ICD-10 code description
Opioid dependence Cannabis dependence
Primary outcomes
1
Description
Craving in patients with substance use disorder
Timepoint
One day before starting treatment, one day after the end of treatment, two months after the end of treatment.
Method of measurement
Desire for Drug Questionnaire (DDQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who are treated with active rTMS, receive 12 active rTMS sessions with a frequency of 10 Hz, 3 times a week for 4 consecutive weeks. The cap of the device is placed on the patient's head, and they receive stimulation in the Left Dorsolateral Prefrontal Cortex (Left DLPFC).
Category
Treatment - Other
2
Description
Control group: Patients receiving sham stimulation. Patients connect to the rTMS device, and the cap of the device is placed on the Patients head, but they receive sham stimulation. 12 sham rTMS session with a frequency of 0 Hz, 3 times a week for 4 consecutive weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Zanjan
Full name of responsible person
Farzaneh Araghi
Street address
Besat
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
beheshti@zums.ac.ir
Web page address
http://beheshti.zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Reasearch assistant of Zanjan University of Medical Sciences Dr. Samad Nadri
Street address
ِDr. Sobooti Blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3342 0651
Fax
+98 24 3344 9553
Email
medicine@ zums.ac.ir
Web page address
http://zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Elham Faghih Zadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Faculty of Medicine, Karmandan town, Mahdavi Blv
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3344 0300
Fax
+98 24 3344 9553
Email
e.faghihzadeh@zums.ac.ir
Web page address
http://zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mina Shabani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Darvazeh Ark, Besat street
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
manaz@zums.ac.ir
Web page address
http://beheshti.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nafiseh Bay
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Darvazeh Ark, Besat street
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
Nafise_bay@yahoo.com
Web page address
http://beheshti.zums.ac.ir
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
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
Title and more details about the data/document
The data can be published after the individuals are not identified.
When the data will become available and for how long
When publishing results
To whom data/document is available
Researchers working in academic and scientific institution
Under which criteria data/document could be used
For scientific research
From where data/document is obtainable
Library of Zanjan University of Medical Sciences
What processes are involved for a request to access data/document