The efficacy of transcranial direct current stimulation of dorsolateral prefrontal cortex on modulation of anxiety and craving in crystalline heroin dependents in MMT program.
The present study is a semi-experimental, double-blinded, and cross over study with pre and post- test, and control group. The aim of the present study is to test the possibility of craving and anxiety reduction in crystalline heroin users in MMT program by (tDCS), on dorsolateral prefrontal cortex. Participants are the whole population of right- handed male crystalline heroin users in MMT program who were referred to drug addiction treatment and rehabilitation centers in Tehran. According to inclusion criteria, 40 people who get the highest marks in DDQ and HAMA will be selected based on available sampling method and they will be divided into experimental and control groups with 20 subjects in each, randomly. Sham stimulation will be applied for experimental group at first session. Anodal right and cathodal right tDCS will be apply for experimental group randomly during 2 sessions on their dorsolateral prefrontal cortex. To omit the carry over effect of multiple stimulations, the experiments will be performing at 72 hrs intervals. The control group will get the sham stimulation on the same spot for 20 min in 1 session. Drug Desire Questionnaire (DDQ) and Hamilton anxiety scale (HAMA) will be administered to all of the subjects, before initiation of the brain stimulation, and by the end of it. The data will be analyzed by use of covariance method by SPSS software for examining the reduction of anxiety and craving.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120625384N1
Registration date:2016-01-24, 1394/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-24, 1394/11/04
Registrant information
Name
Mona Sharifi Fardshad
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 4415 7935
Email address
behjoobraincenter@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator and Behjoo Brain Center
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-17, 1394/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of transcranial direct current stimulation of dorsolateral prefrontal cortex on modulation of anxiety and craving in crystalline heroin dependents in MMT program.
Public title
Efficacy of transcranial direct current stimulation in reduction of anxiety and crystalline heroin craving.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 25 to 50 year-old; right handed male; crystalline heroin smokers, with a history of at least 12 and at most 24 months of crystalline heroin dependence based on DSM-V criteria. Subjects at least have five years education, and are able to read, and understand the questions. Accept and sign the consent form. Exclusion criteria: any current or past major clinical neurologic disorders; central nervous system-effective medication intake; history of epilepsy; brain surgery; brain tumor; intracranial metal implantation; clinically significant head trauma, or any major clinical psychiatric disorders (in axis I, except substance-related disorders).
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Karaj Branch
Street address
Shahid Moazen and Esteghlal Blvd. Rajaei Shahr, Karaj
City
Rajaei Shahr
Postal code
313-31485
Approval date
2014-05-06, 1393/02/16
Ethics committee reference number
63820705922017
Health conditions studied
1
Description of health condition studied
Crystalline Heroin Dependence
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after stimulation
Method of measurement
Hamilton Anxiety Scale
2
Description
Instant craving
Timepoint
Before and after stimulation
Method of measurement
Drug Desire Questionnair
Secondary outcomes
1
Description
tDCS side effects
Timepoint
After stimulation
Method of measurement
tDCS side effects check list
Intervention groups
1
Description
Direct current will be delivered from a constant current stimulator (ActivaDose), and will be transferred by a pair of (35 cm2) electrodes with stimulation intensity of 2mA. Electrodes are standard carbonic, covered with a normal saline soaked sponge cases. In current stimulations (right anodal/left cathodal), the anod electrod will be placed on the right DLPFC (F4), and the cathode electrod will be placed on the left DLPFC (F3). In current stimulations (right cathodal/left anodal), the cathod electrod will be placed on the right DLPFC (F4), and the anod electrod will be placed on the left DLPFC (F3). The stimulation will be performed randomly for subjects in the experimental group during 2 sessions. Subjects in experimental groups will receive sham stimulation at first session. The only difference in this kind of stimulation is that the current will cut after 30s and primarily itching and sting will be felt by the subject. The Stimulation will be done for 20min. To omit the carry over effect of multiple stimulations, the experiments were performed at 72 hrs intervals.
Category
Treatment - Devices
2
Description
Direct current will be delivered from a constant current stimulator (ActivaDose), and will be transferred by a pair of (35 cm2) electrodes with stimulation intensity of 2mA. Electrodes are standard carbonic, covered with a normal saline soaked sponge cases. Subjects in control group will receive sham stimulation in 1 session. The only difference in this kind of stimulation is that the current will cut after 30s and primarily itching and sting will be felt by the subject. The Stimulation will be done for 20min.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Behjoo Brain Center
Full name of responsible person
Peyman Hassani Abharian
Street address
Sattarkhan After Asadi Street
City
Tehran
2
Recruitment center
Name of recruitment center
Taghdir
Full name of responsible person
Gite Ghorbani
Street address
Sadeghyeh Sazman-e- Aab Street 9th Strett
City
Tehran
3
Recruitment center
Name of recruitment center
Sayeh Center
Full name of responsible person
Dr. Nikbakht
Street address
Ferdos Blvd. Valiasr Strett Etemadian Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behjoo Brain Center
Full name of responsible person
Peyman Hassani Abharian
Street address
Sattarkhan Street, After Asadi Stret
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?