Protocol summary
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Study aim
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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
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Design
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A clinical trial was conducted on 30 subjects in two groups of control and blinded, blind, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Craving، relapse، depression، anxiety، stress، sleep quality
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180604039979N1
Registration date:
2018-06-18, 1397/03/28
Registration timing:
registered_while_recruiting
Last update:
2019-02-03, 1397/11/14
Update count:
1
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Registration date
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2018-06-18, 1397/03/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-11, 1397/03/21
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Expected recruitment end date
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2019-02-19, 1397/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of tDCS on Opioid patients under methadone maintenance treatment
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Subjects are randomly assigned to one of two study groups using the random numbers table
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-28, 1397/03/07
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1397.009
Health conditions studied
1
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Description of health condition studied
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Addiction
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ICD-10 code
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F11.14
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ICD-10 code description
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Opioid abuse with opioid-induced mood disorder
2
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Description of health condition studied
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Addiction
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ICD-10 code
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F11.182
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ICD-10 code description
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Opioid abuse with opioid-induced sleep disorder
Primary outcomes
1
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Description
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Reduce craving
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Timepoint
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Fourth and seventh session of intervention
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Method of measurement
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desire for drug questionnaire(DDQ)
2
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Description
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Reduce relaps
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Timepoint
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Fourth and seventh session of intervention
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Method of measurement
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Urine test
3
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Description
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Reduce depression
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Timepoint
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Fourth and seventh session of intervention
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Method of measurement
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Depression, Anxiety and stress Scales (DASS-21)
4
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Description
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Reduce anxiety
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Timepoint
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Fourth and seventh session of intervention
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Method of measurement
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Depression, Anxiety and stress Scales(DASS-21)
5
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Description
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Reducing stress
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Timepoint
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Fourth and seventh session of intervention
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Method of measurement
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Depression, Anxiety and stress Scales(DASS-21)
6
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Description
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sleep quality
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Timepoint
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Fourth and seventh session of intervention
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Method of measurement
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Pittsburgh Sleep Quality Index(PSQI)
Intervention groups
1
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Description
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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)
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Category
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Treatment - Other
2
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Description
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Control group: Exactly for the control group, but, it is performed as a sham and placebo
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The original outcome data can be shared
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When the data will become available and for how long
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Start the access period 12 months after publishing the results
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To whom data/document is available
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For scholars working in academia and academia
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Under which criteria data/document could be used
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Can be used for related studies
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From where data/document is obtainable
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sadeghi6637@yahoo.com Mohammad sadeghi bimorgh
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What processes are involved for a request to access data/document
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The request is sent via email, sent within a maximum of two weeks
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Comments
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