Protocol summary

Summary
The method was Quasi-experimental with pretest-posttest designs with control group. 44 patients were selected through convenient sampling and were randomly assigned into two exprimental and control groups. Before the treatment, both groups were tested through craving questionnaire and cmputerized emotional stroop test.The experimental group received a 20 minute electrical stimulation of the brain by stimulator with the intensity of 2 mA for 10 session.at the end, both groups were tested through craving questionnaire and cmputerized emotional stroop test and the data were analysed with MANCOVA and ANCOVA

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061233946N2
Registration date: 2017-06-13, 1396/03/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-13, 1396/03/23
Registrant information
Name
Mohsen Dadashi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3353 4500
Email address
mohsendadashi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectivness of anodal transcranial direct current stimulation(tDCS) over left dorsolateral prefrontal cortex on drug craving and attentional bias symptoms in opium addictied males
Public title
Effectivness of anodal transcranial direct current stimulation(tDCS) over left dorsolateral prefrontal cortex on drug craving and attentional bias symptoms in opium addictied males
Purpose
Treatment
Inclusion/Exclusion criteria
Drug dependence; no psychotic disorder; no delusional disorder; age range 24-45; male; under treatment with methadone (MMT); no anti-psychotic drug administration.
Age
From 25 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zanjan Islamic Azad University .,Zanjan, Iran
Street address
Zanjan Islamic Azad University .,Zanjan, Iran
City
zanjan
Postal code
Approval date
2015-07-21, 1394/04/30
Ethics committee reference number
62620701942064

Health conditions studied

1

Description of health condition studied
Opium addiction
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids

Primary outcomes

1

Description
Craving
Timepoint
Before and after intervention
Method of measurement
Craving questionnaire

Secondary outcomes

1

Description
Drug craving and attentional bias symptoms in opium addictied males
Timepoint
Before and after intervention
Method of measurement
Craving questionnaire and cmputerized emotional stroop test

Intervention groups

1

Description
Before the treatment, both groups were tested through craving questionnaire and cmputerized emotional stroop test.The experimental group received a 20 minute electrical stimulation of the brain by stimulator with the intensity of 2 mA for 10 session
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ofog MMT center
Full name of responsible person
Street address
City
Bijar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bijar MMT center
Full name of responsible person
Dr. Tabatabaie
Street address
Bijar MMT center
City
Bijar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bijar MMT center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Mohsen Dadashi, Assistant Professor, PhD in Clinical Psychology
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
psy.mohsen@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Assistant Professor, PhD in Clinical Psychology
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
psy.mohsen@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Mohsen Dadashi, Assistant Professor, PhD in Clinical Psychology
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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