The effect of Transcranial Direct Current Stimulation(tDCS) on craving, relaps and mental health parameters in Opioid patients under methadone maintenance treatment
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Protocol summary
A clinical trial was conducted on 18 subjects in two groups of control and blinded, blind, randomized
A clinical trial was conducted on 30 subjects in two groups of control and blinded, blind, randomized
A clinical trial was conducted on 1830 subjects in two groups of control and blinded, blind, randomized
کارآزمایی بالینی 18 نفر در دو گروه کنترل وآزمون ، دو سویه کور ، تصادفی شده
کارآزمایی بالینی 30 نفر در دو گروه کنترل وآزمون ، دو سویه کور ، تصادفی شده
کارآزمایی بالینی 1830 نفر در دو گروه کنترل وآزمون ، دو سویه کور ، تصادفی شده
In intervention groups nine subjects receive 7 sessions، 2 MA current for 20 minutes every other day in the F4 (anode) and F3 (cathode) regions of the skull, and 9 subject in control group receive the same current
In intervention groups Fifteen subjects receive 7 sessions، 2 MA current for 20 minutes every other day in the F4 (anode) and F3 (cathode) regions of the skull, and Fifteen subject in control group receive the same current
In intervention groups nineFifteen subjects receive 7 sessions، 2 MA current for 20 minutes every other day in the F4 (anode) and F3 (cathode) regions of the skull, and 9Fifteen subject in control group receive the same current
9نفرگروه مداخله 7 جلسه تحریک الکتریکی مستقیم فراجمجمه ای دو میلی آمپربه مدت 20 دقیقه بصورت روز درمیان در نواحی اف4(آند) واف3(کاتد)جمجمه دریافت می نمایندو9نفرگروه کنترل هم به همین صورت جریان شم دریافت می کنند
15نفرگروه مداخله 7 جلسه تحریک الکتریکی مستقیم فراجمجمه ای دو میلی آمپربه مدت 20 دقیقه بصورت روز درمیان در نواحی اف4(آند) واف3(کاتد)جمجمه دریافت می نمایندو9نفرگروه کنترل هم به همین صورت جریان شم دریافت می کنند
9نفرگروه15نفرگروه مداخله 7 جلسه تحریک الکتریکی مستقیم فراجمجمه ای دو میلی آمپربه مدت 20 دقیقه بصورت روز درمیان در نواحی اف4(آند) واف3(کاتد)جمجمه دریافت می نمایندو9نفرگروه کنترل هم به همین صورت جریان شم دریافت می کنند
General information
18
30
1830
2018-09-22, 1397/06/31
2019-02-19, 1397/11/30
20182019-0902-2219 00:00:00
Protocol summary
Study aim
The purpose of this study was to determine the rate of recovery of craving, relapse, depression, anxiety, stress and sleep quality in patients undergoing methadone maintenance therapy
Design
A clinical trial was conducted on 30 subjects in two groups of control and blinded, blind, randomized
Settings and conduct
Sampling will be done at addiction treatment centers of Mashhad University of Medical Sciences and patients who have had opioids and they are treated with methadone.subjects before the intervention, after the fourth and the last session of the intervention, are examined by the questionnaire's survey tool. The study is double-blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Diagnosis of drug abuse and opiate dependence by a psychiatrist, Methadone intake in less than a year, having At least grade nine, completing Informed consent, aged 18-60 years
exclusion criteria:
Progressive disease such as diabetes, brain stroke and seizures،metal prostheses in skull،Having a heart pacemaker،Having psychotic diseases،abuse of other substances other than methadone،Reluctance to participate in research
Intervention groups
In intervention groups Fifteen subjects receive 7 sessions، 2 MA current for 20 minutes every other day in the F4 (anode) and F3 (cathode) regions of the skull, and Fifteen subject in control group receive the same current
The effect of Transcranial Direct Current Stimulation(tDCS) on craving, relaps and mental health parameters in Opioid patients under methadone maintenance treatment
Public title
The effect of tDCS on Opioid patients under methadone maintenance treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of drug abuse and dependence on opioids under methadone maintenance treatment according to DSM-V diagnostic criteria by a specialist psychiatrist
The patient only receives methadone treatment
Methadone maintenance treatment for at least one year
Have at least 9th grade literacy
Complete informed consent
Aged 18-60 years
Exclusion criteria:
Having any progressive disease, such as diabetes and neurological diseases, especially a history of head truma and seizure
Having metal objects or prostheses in head
Having a shunt on the skull and pacemaker in the heart
The presence of severe psychiatric illnesses in the I axis based on DSM-V diagnostic criteria: such as psychotic disorders
Taking other medicines in addition to methadone (such as morphine, hashish, glass)
Unwilling to participate in research
Age
From 18 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly assigned to one of two study groups using the random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and researcher are blinded, but the research assistant is not blind. research assistant regulate device on real or sham mode in the case group or the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Researches of Kashan Medical School
Street address
Gotbe Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
88715973474
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.009
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F11.14
ICD-10 code description
Opioid abuse with opioid-induced mood disorder
2
Description of health condition studied
Addiction
ICD-10 code
F11.182
ICD-10 code description
Opioid abuse with opioid-induced sleep disorder
Primary outcomes
1
Description
Reduce craving
Timepoint
Fourth and seventh session of intervention
Method of measurement
desire for drug questionnaire(DDQ)
2
Description
Reduce relaps
Timepoint
Fourth and seventh session of intervention
Method of measurement
Urine test
3
Description
Reduce depression
Timepoint
Fourth and seventh session of intervention
Method of measurement
Depression, Anxiety and stress Scales (DASS-21)
4
Description
Reduce anxiety
Timepoint
Fourth and seventh session of intervention
Method of measurement
Depression, Anxiety and stress Scales(DASS-21)
5
Description
Reducing stress
Timepoint
Fourth and seventh session of intervention
Method of measurement
Depression, Anxiety and stress Scales(DASS-21)
6
Description
sleep quality
Timepoint
Fourth and seventh session of intervention
Method of measurement
Pittsburgh Sleep Quality Index(PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 7 sessions and receive tDCS electrical stimulation every two days. This electrical stimulation by the tDCS device at 2 mAh for 20 minutes will be a right and left / left cathode assembly and will be applied using a pair of carbon electrodes of 35 cm2 in area with a sponge pad covered with saline. Electrodeposition (positive) on the RightDLPFC (F4) and electrodes (negative) to be placed on left DLPFC(F3)
Category
Treatment - Other
2
Description
Control group: Exactly for the control group, but, it is performed as a sham and placebo