Evaluation of the effectiveness of electrical extracranial stimulation of the brain (TDCS) combined with matrix psychotherapy in comparison with matrix psychotherapy alone in reducing cravings and improving cognitive functions in the methamphetamine withdrawal phase
This therapeutic method- that is used along with other common psychotherapies in stimulants addiction to evaluate the effectiveness of electrical stimulation of brain in controlling and reducing drug craving among methamphetamine addicts- can be considered as an effective method in methamphetamine addiction treatment. Accordingly, this study was conducted to examine effectiveness of brain electrical stimulation along with psychotherapy in reducing methamphetamine craving compared to the psychotherapy used alone.
Design
The clinical trial consists of three groups of 11, 8, and 9 individuals, not blinded, randomized.
Settings and conduct
Iranian Family Rehabilitation Center in Karaj
Participants/Inclusion and exclusion criteria
Inclusion criteria were as follows: patients who had referred to the common accommodation a, having at least 12-month experience of methamphetamine addiction based on the DSM-5 criteria, avoiding any drug or stimulant abuse except for cigarette, drug abuse in 6 days a week, consent signing of ethical form. Exclusion criteria included having any psychiatric disorder except for drug-related disorders, traumatic brain injuries، having metal implants inside the skull, mental retardation, organic brain disorder, having serious suicidal thoughts, receiving another medical or psychological intervention at the same time.
Intervention groups
11 patients of group 1 received tDCS with craving therapy protocol during 15 sessions; and 24 sessions of psychological therapy
8 patients in group received 15 sessions tDCS with craving treatment protocol through shame method and without effectiveness; they also received 24 sessions of psychological therapy
9 patients in group 3 just received 24 sessions of psychological therapy
Main outcome variables
Craving (outcome); Cognitive functions (outcome)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030510N3
Registration date:2020-09-29, 1399/07/08
Registration timing:retrospective
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Reza Arezoomandan
Name of organization / entity
Addiction Department, School of Behavioral Sciences and Mental Health (Institute of Tehran Psychiatr
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1658
Email address
arezoomandan.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-11-11, 1398/08/20
Actual recruitment end date
2020-03-20, 1399/01/01
Trial completion date
2020-05-10, 1399/02/21
Scientific title
Evaluation of the effectiveness of electrical extracranial stimulation of the brain (TDCS) combined with matrix psychotherapy in comparison with matrix psychotherapy alone in reducing cravings and improving cognitive functions in the methamphetamine withdrawal phase
Public title
Evaluation of the effectiveness of electrical extracranial stimulation of the brain (TDCS) combined with matrix psychotherapy in comparison with matrix psychotherapy alone in reducing cravings and improving cognitive functions in the methamphetamine withdrawal phase
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had referred to the common accommodation and outpatient treatment center in order to quite methamphetamine addiction
Having at least 12-month experience of methamphetamine addiction based on the DSM-5 criteria
Drug abuse in 6 days a week,
Avoiding any drug or stimulant abuse except for cigarette
Age: 18-50,
Consent signing of ethical form.
Exclusion criteria:
Having any psychiatric disorder except for drug-related disorders,
Traumatic brain injuries (medium to severe) along with neurologic deficits or suffering from acute and unstable medical conditions that may put the patient at risk,
Having metal implants inside the skull, mental retardation, organic brain disorder, having serious suicidal thoughts,
Receiving another medical or psychological intervention at the same time.
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization performed with simple method and random numbers generated by computer software (Stat Trek) which choose the random numbers.Then, we consider the specific numbers for both groups for example: the even numbers are for experimental group and odd numbers are for the control group.
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
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Shahid Hemmat Highway; Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.IUMS.REC.1397.139
Health conditions studied
1
Description of health condition studied
Methamphetamine abusers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Craving Score in Craving questionnaire
Timepoint
Before and after the intervention
Method of measurement
Craving questionnaire or OCDUS - Obsessive Compulsive Drug Use Scale
2
Description
Working memory score in Wechsler subscale
Timepoint
Before and after the intervention
Method of measurement
The digit span subscale of Wechsler Intelligence Scale
3
Description
Cognitive function score in Wisconsin Scale
Timepoint
Before and after the intervention
Method of measurement
Wisconsin Test
Secondary outcomes
empty
Intervention groups
1
Description
Rreal tDCS: 11 patients in this group received tDCS with craving therapy protocol during 15 sessions; they also received 24 sessions of psychological therapy based on the matrix protocol. Therapeutic protocol of intervention group (real TDCS) included 2MA current for 20 minutes in form of DC current. In this research, the direct electrical current was received from an electric current generator that works with batteries then transferred to a pair of electrodes 5×7 (35 cm2). Carbon electrodes were placed inside the sponge coating impregnated with serum.The matrix protocol includes: a variety of psychological therapies for patients
Category
Rehabilitation
2
Description
Sham tDCS: 8 patients in group received 15 sessions tDCS with craving treatment protocol through shame method and without effectiveness (without informing the patient); they also received 24 sessions of psychological therapy based on the matrix protocol. The matrix protocol includes: a variety of psychological therapies for patients
Category
Rehabilitation
3
Description
Control group: 9 patients in group 3- as a control group- just received 24 sessions of psychological therapy based on the matrix protocol. The matrix protocol includes: a variety of psychological therapies for patients
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Family Rehabilitation Center
Full name of responsible person
Reza arezoomandan
Street address
North Taleghani Street
City
Karaj
Province
Alborz
Postal code
0000000000
Phone
+98 21 3221 9703
Email
Arezoomandan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Motavlian
Street address
Iran University of Medical Sciences, Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
.
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
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Arezoomandan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mansouri St, Faculty of Behavioral Sciences and Mental Health
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
Arezoomandan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Reza Arezoomandan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mansouri St., Faculty of Behavioral Sciences and Mental Health
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1555
Email
Arezoomandan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza arezoomandan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mansouri St., Faculty of Behavioral Sciences and Mental Health
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1555
Email
Arezoomandan@yahoo.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical and cognitive outcomes of patients after the intervention
When the data will become available and for how long
2020
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers from all scientific centers
From where data/document is obtainable
Email
What processes are involved for a request to access data/document