This study deals with the investigation of the efficacy of transcranial direct current stimulation (tDCS) concerning the treatment of the opiate addiction via the UROD approach. It is a randomized, double blind, sham controlled survey. The Inclusion criteria is the diagnosis of the addiction to the opiates according to DSMIV criteria and the psychiatrist’s idea. Patients with important somatic diseases or of any history of seizure are excluded. Forty chronic opioid addicts who refrain from the use of the drug from the night before the procedure is carried out, are randomly assigned to receive sham or the real mode of tDCS once a day for three successive sessions. The location of the anodal electrode is on the right dorsolateral prefrontal cortex while the cathode is on the left. The intensity of the electrical current is 2mA lasting 20 minutes per session. Craving, withdrawal syndrome and the relapse are assessed before the intervention and during the period of the next 3 months.
General information
Acronym
tDCS-UROD
IRCT registration information
IRCT registration number:IRCT2015022821273N1
Registration date:2015-04-04, 1394/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-04, 1394/01/15
Registrant information
Name
Hamid Mirhosseini
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35138224263
Email address
mirhosseini@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2015-03-08, 1393/12/17
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Transcranial direct current stimulation effects on the treatment of the opiate addiction in Ultra rapid opioid detoxification method
Public title
Effect of the brain stimulation with very weak electrical current in opiod addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Diagnostic criteria for opiate dependence defined by Diagnostic and Statistical Manual of Mental Disorders (4th ed.) (DSM-IV);
Inhalational application route;Literate; last usage at the night before;male gender Exclusion criteria: Siezure or any history of convulsion which has been prohibited for tDCS;Cardiopulmomary or Hepatic diease or any sensitivity to anesthetics which have been prohibited for general anesthesia; Comorbidy of other psychiatric disorders such as psychosis,anxiety,mood and affective disorder;Amphetamine,Alcohol and sedatives abuse
Age
No age limit
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of medical science
Street address
Headquarters of University, Bahonar square, Yazd
City
Yazd
Postal code
8916978477
Approval date
2014-06-02, 1393/03/12
Ethics committee reference number
17/1/47840/پ
Health conditions studied
1
Description of health condition studied
opiod addiction
ICD-10 code
Z71.5
ICD-10 code description
Drug abuse counselling and surveillance
Primary outcomes
1
Description
craving
Timepoint
before,afte rand 1,3,12hrs and 2weeks,1,3months after treatment
Method of measurement
DDQ questionary
2
Description
withdrawal syndrom
Timepoint
before,afte rand 1,3,12hrs and 2weeks,1,3months after treatment
Method of measurement
OOWS questionary
3
Description
relapse
Timepoint
2 weeks,1 & 3 months after treatment
Method of measurement
Interviews & Urine strip test
Secondary outcomes
1
Description
irritation of electrode location
Timepoint
after the last intervention
Method of measurement
observation
Intervention groups
1
Description
intervention group:We will apply real mode of tDCS once a day for three successive sessions. anodal electrode will locate on the right dorsolateral prefrontal cortex(DLPFC) and cathode on the left one. The intensity of electrical current is 2mA for 20 minutes through each session. Direct current will be transferred by using a saline-soaked pair of surface sponge
Category
Treatment - Devices
2
Description
control group:We will apply sham mode of tDCS once a day for three successive sessions. anodal electrode will locate on the right dorsolateral prefrontal cortex(DLPFC) and cathode on the left one.Since the study is double blind,device will remain for20 minutes. The intensity of electrical current is 2mA for 30 seconds through each session and then the device will be put out. Direct current will be transferred by using a saline-soaked pair of surface sponge
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Bahman clinic of psychiatery
Full name of responsible person
Dr Yassini
Street address
Bahman clinic, Kashani Ave, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Science
Full name of responsible person
Dr Yassini
Street address
Headquarters of Medical University, Bahonar square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?