Evaluation of the effect of direct transcranial electrical stimulation on cravings and slippage in the use of opioid patients undergoing maintenance treatment
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 48 patients. The com.Randomaize site was used for randomization
Settings and conduct
Ibn Sina Hospital Outpatient Clinic and Psychiatric Clinics
Participants are then randomly divided into experimental and sham groups. Both groups are connected to the transcranial electrical stimulation device ten times a day
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Completing the informed consent form.
Age between 18 to 60 years.
Negative rapid urine drug test.
.
Exclusion Criteria:
addiction to non-opioids drugs
History of epilepsy.
Metal or prosthesis or implant in the skull.
Significant physical disease.
Serious physiological or psychiatric disorders that are effective in the .intervention
Other acute and chronic psychiatric disorders other than addiction.
Intervention groups
All subjects will receive direct transcranial electrical stimulation for 6 sessions every other day for 20 minutes in each session (direct stimulation with a current intensity of 2 mA).
Stimulation zones: anode in F3 region and cathode in F4 region
Device name: tDcs
Main outcome variables
The patient's craving for substances is measured before the start of electrical stimulation sessions and after interventions by the substance craving questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N49
Registration date:2022-03-25, 1401/01/05
Registration timing:registered_while_recruiting
Last update:2022-03-25, 1401/01/05
Update count:0
Registration date
2022-03-25, 1401/01/05
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcranial direct current stimulation (tDCS) on craving and lapse in opioid patients under methadone maintenance treatment
Public title
The effect of transcranial direct current stimulation (tDCS) on craving Opioid use
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Completing the informed consent form
Age between 18 to 60 years
Negative rapid urine drug test
Have been on methadone treatment for at least 1 month
Have a history of opium addiction and methadone treatment
Exclusion criteria:
Having a metal or prosthesis or implant in the skull
dependence on non-opioids such as Methamphetamine
Existence of other moderate and chronic psychiatric disorders other than consumption
Having a significant physical illness
Have a history of epilepsy or severe concussion
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
This is how random numbers are prepared with the help of Randomaize.com. According to the number of research samples, a number of envelopes with wrappers
Aluminum (in order to avoid the clarity of the contents of the envelopes), is prepared and each of the random sequences created is registered on a card and the cards are placed inside the envelopes. In order to protect the random sequence, also on the outer surface of the envelopes
Numbering is done in the same way. Finally, the lids of the letter envelopes are glued and placed in a box, respectively.
At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order, and the envelopes contain the odd number of the control group and the envelopes contain the even number of the group.
Open in Google Trans
Blinding (investigator's opinion)
Double blinded
Blinding description
Each subjects will be assigned a code. The subjects and those assessing the outcome will be blinded to the type of intervention received by the participant.
Placebo
Not 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 Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2021-05-11, 1400/02/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.418
Health conditions studied
1
Description of health condition studied
The subject of study is not a disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of craving for substances
Timepoint
It is measured before the start of electrical stimulation sessions and after interventions
Method of measurement
By the questionnaire of the tendency to use substances
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ten sessions will be held every other day for twenty minutes with 2 mA electric current intensity. The transcranial electrical stimulation device (tDCS) has two poles and a cathode that connects to the right and left regions of the DLPFC. The anode is placed in the F3 region and the cathode in the F4 region. After connection, the device is turned on and the electric current is actually turned on.
Category
Treatment - Other
2
Description
Control group: In the control group, the device is connected to feel the initial burning of the skin in the area below the electrode, but the difference with the intervention group is that no current is established here (the device is in sham position).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital
Full name of responsible person
Masoumeh khoshkbarchi
Street address
Khorasan Razavi Province Mashhad Mashhad - Bouali Square
City
MASHHAD
Province
Razavi Khorasan
Postal code
345 -91357
Phone
+98 51 3711 2701
Email
khoshkbarchim981@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
مجیدغیور
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
MASHHAD
Province
Razavi Khorasan
Postal code
345 -91357
Phone
+98 51 3841 2081
Email
GhayourM@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
Ali Talaei
Position
استاد
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mashhad, Bu Ali Square, Ibn Sina Psychiatric Hospital
City
MASHHAD
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 935 538 0238
Email
talaeia@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Talaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mashhad, Bu Ali Square, Ibn Sina Psychiatric Hospital
City
MASHHAD
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
talaeia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ali Talaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mashhad, Bu Ali Square, Ibn Sina Hospital
City
MASHHAD
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 935 538 0238
Email
talaeia@mums.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