Protocol summary

Study aim
Assessment of tDCS effect on drug craving, ERP amplitudes and neuronal activity by a cue-induced craving paradigm in abstinent methamphetamine users. Predicting the tDCS effect on drug craving by rest EEG.
Design
Two arms parallel group, randomized, double-blind,sham-controlled trial. Randomisation will be carried out by Matlab software.
Settings and conduct
EEG will be recorded during 5 minutes eye open and 5 minutes eye closed Pre and Pos tDCS. A visual cue reactivity paradigm immediately before and after tDCS will be conducted to elicit ERPs . Immediate drug craving will be assessed at four-time points of pre and post tDCS. We will use Starstim to brain stimulation and g.HIamp for EEG recording in National Brain Mapping Laboratory . A third party will select two codes for sham/active tDCS session, who will not involve in data acquisition and analyses.due to tDCs
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male; Age ≥18 and <61 years old; Diagnosed with Methamphetamine Use Disorder; Positive response to Methamphetamine cue-reactivity screening. Abstinent from any drugs except cigarettes for at least one week. Exclusion criteria: Abstinence from methamphetamine for more than 6 months; History of major head trauma, seizure, brain surgery, intracranial metal implantation Positive drug test for amphetamines, opioids, cannabis confirmed by urine tests
Intervention groups
Participants randomly undergo one active (intervention group) or sham (control group) 2 mA-tDCS session.
Main outcome variables
The amplitude change of EAP, P3 and LPP and change of neuronal activities due to tDCs. Predicting The effect of tDCS on drug craving by rest EEG.

General information

Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number: IRCT20170808035562N2
Registration date: 2018-06-16, 1397/03/26
Registration timing: prospective

Last update: 2018-06-16, 1397/03/26
Update count: 0
Registration date
2018-06-16, 1397/03/26
Registrant information
Name
Hassan Khajehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 6383
Email address
h-khajehpoor@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of transcranial direct current stimulation on drug cue-induced craving in abstinent methamphetamine users using a visual paradigm and its prediction using resting state EEG signals
Public title
ٍEffect of transcranial direct current stimulation on drug craving of addicts
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender Age ≥18 and <61 years old Farsi speaking Diagnosed with Methamphetamine Use Disorder (last 12 months) based on Structured Clinical Interview for DSM-5 (SCID-5) Abstinent from any drugs except cigarettes for at least one week based on medical records or self-report, confirmed by urine analysis Positive response to Methamphetamine cue-reactivity screening (MCS) Willing and capable of interacting with the informed consent process8. The ability to understand, read and answer the tests
Exclusion criteria:
Unwillingness or inability to complete any of the major aspects of the study protocol, including drug cue rating, or behavioral assessment. Abstinence from methamphetamine for more than 6 months based on self-report Any major clinical psychiatric disorder, assessed by Structured Clinical Interview for DSM-5 (SCID-5) Active suicidal ideation with intent or plan determined by self-report or assessment by PI or study staff during the initial screening or any other phase of the study Positive drug test for amphetamines, opioids, cannabis confirmed by urine tests Any active skin disorder that affects skin integrity of the scalp Having any condition that would preclude undergoing a tDCS stimulation based on the tDCS safety checklist Unstable medical disorder reported in subject’s medical history or by a clinician assessment History of major head trauma, seizure, brain surgery, intracranial metal implantation Non-correctable vision or hearing problems.
Age
From 18 years old to 61 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants randomly undergo one active or sham tDCS session. The randomization procedure will be performed by Matlab software. A binary randome sequence with length 60 will be generated.
Blinding (investigator's opinion)
Double blinded
Blinding description
We will use STARSTIM for electrical brain stimulation located in National Brain Mapping Laboratory (NBML). This device has the capability to assign codes to different stimulation states (active and sham). One of NBML staffs who is not engaged in our project will select this codes. Participants, investigator, and data analyzer are uninformed that which code is related to sham or active states.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences , Pursina St, District 6, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653861
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.TUMs.MEDICINE.REC.1395.1621

Health conditions studied

1

Description of health condition studied
Methamphetamine dependence disorder
ICD-10 code
F11.2
ICD-10 code description
Opioid dependence

Primary outcomes

1

Description
Amplitude of event-related potentials with middle latency (P3)
Timepoint
Immediately before and after intervention
Method of measurement
Event-related potentials will be recorded using a bio-signal amplifier with CE & FDA approval (g.HIamp, g.tec company ) from 62 scalp sites.

2

Description
Amplitude of event-related potentials with late latency (LPP)
Timepoint
Immediately before and after intervention
Method of measurement
Event-related potentials will be recorded using a bio-signal amplifier with CE & FDA approval (g.HIamp, g.tec company ) from 62 scalp sites.

3

Description
Amplitude of event-related potentials with early latency (<300 ms)
Timepoint
Immediately before and after intervention
Method of measurement
Event-related potentials will be recorded using a bio-signal amplifier with CE & FDA approval (g.HIamp, g.tec company ) from 62 scalp sites.

Secondary outcomes

1

Description
Functional brain connectivity
Timepoint
Before intervention-after intervention
Method of measurement
Weighted Phase Lag Index

2

Description
Effective brain connectivity
Timepoint
Before intervention-after intervention
Method of measurement
Granger causality method

3

Description
ٍelectric neuronal activities
Timepoint
Before intervention-after intervention
Method of measurement
Source reconstruction methods such as Standardized low-resolution brain electromagnetic tomography (sLORETA)

4

Description
Craving for Methamphetamin
Timepoint
Before, during & after
Method of measurement
Visual Analogue Scale (VAS)

5

Description
Craving for Methamphetamine
Timepoint
Before & after
Method of measurement
Desire for Drug Questionnaire

6

Description
Depression
Timepoint
After intervention
Method of measurement
Depression Anxiety and Stress Scale (DASS)

7

Description
Impulsivity
Timepoint
After Intervention
Method of measurement
Barratt Impulsiveness Scale

8

Description
Positive & Negative Affect
Timepoint
Before and After Intervention
Method of measurement
Positive and Negative Affect Scale

9

Description
Anxiety
Timepoint
After Intervention
Method of measurement
Depression Anxiety and Stress Scale (DASS)

10

Description
Stress
Timepoint
َبفثق هدفثقرثدفهخد
Method of measurement
Depression Anxiety and Stress Scale (DASS)

Intervention groups

1

Description
Intervention group: Direct current will be delivered using a StarStimtCS system and transferred by a pair of circular stimulation electrodes with 1 cm radius. They have rear-fill apertures allows for gel supply. Anode/cathode electrodes will respectively be placed over F3 and F4 electrodes (EEG 10/20 system) to target the right and left dorsolateral prefrontal cortex (rDLPFC). During anodal tDCS, a 2 mA current will be applied for 20 min.
Category
Treatment - Devices

2

Description
Control group: StarStimtِCS system with a pair of circular stimulation electrodes with 1 cm radius will be used. Anode/cathode electrodes will respectively be placed over F3 and F4 electrodes (EEG 10/20 system). The simulator will be turned off after a gradual ramping up of electrical current to 2 mA and down to 0 mA which took 1 min. The electrodes will be on the scalp for the remaining 18 min and subjects will not be informed that the device is turned off. َAfter that, there will be again a gradual ramping up of electrical current to 2 mA and down to 0 mA which took 1 min.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Khaneh Dust Yaran Residential Center
Full name of responsible person
Ali Kaykani
Street address
No.71, Shayan 1Alley, Persi Gas Ave, 17 Shahrivar Ave, Shad Abad Town, Tehran
City
Tehran
Province
Tehran
Postal code
1188752799
Phone
+98 21 6679 6431
Email
Akaikani@khaneyedoust.com
Web page address
http://www.khaneyedoust.com/

2

Recruitment center
Name of recruitment center
Peyrovan Hemat Reducing Damage Institute
Full name of responsible person
Hassan Jajuei
Street address
No.18, Taheri Alley, Javid Alley, Shahid Moradi Ave, Taavon Boulevard, Shahre Ziba Town, Tehran
City
Tehran
Province
Tehran
Postal code
1199911871
Phone
+98 21 4415 5939
Email
info@phemat.ir
Web page address
http://www.phemat.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr. Shahin Akhondzadeh
Street address
Medicine School, Tehran University of Medical Sciences, Pursina Ave, Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3419
Fax
+98 21 8896 2510
Email
s.akhond@neda.net
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hassan Khajehpour
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No.1, Shahid borhani Alley.Kargar Shomali Ave, Enghelab Squ
City
Tehran
Province
Tehran
Postal code
1417933331
Phone
+98 21 6695 3144
Fax
Email
h-khajehpoor@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahador Makkiabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Medical Physics and Biomedical Engineering Department,Medical School, Tehran University of Medical Sciences, 16 Azar Ave, Pursina Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1417933331
Phone
+98 21 6646 6383
Fax
Email
b-makkiabadi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hassan Khajehpour
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No.1, Shahid borhani Alley.Kargar Shomali Ave, Enghelab Squ
City
Tehran
Province
Tehran
Postal code
1417933331
Phone
+98 21 6695 3144
Fax
Email
h-khajehpoor@razi.tums.ac.ir
Web page address

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
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