Protocol summary
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Study aim
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Craving reduction in Opioids Users
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Design
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In this research, 20 eligible opioids addicts were chosen purposefully that refer to clinics and MMT centers. Then, patients were randomly divided into two neurofeedback and cognitive rehabilitation intervention. Group allocation was concealed by assigning a unique code to each participants.
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Settings and conduct
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20, one hour sessions for every body in neurofeedback group and 15 sessions(each session: 20 minute) for everybody in cognitive rehabilitation group will be done in MMT center. Pre and post tests of intervention groups will be compare with pre and post tests of control groups.
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Participants/Inclusion and exclusion criteria
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a) Inclusion Criteria:
- Written consent to participate in this study
- The patients must use opioids alone
b) Exclusion Criteria:
1.Alcoholic and other substance use patients
2.Addicts that are treated by other drugs such as buprenorphine, opium tincture, tranquilizers
3.Psychotic, bipolar, antisocial, personality disorders and borderline patients.
4.Multi drug abusers.
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Intervention groups
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Opioids users are intervention groups that will be divided to neurofeedback therapy and cognitive rehabilitation groups, and will be compare with intervention group, that are compatible-in number and sex.
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Main outcome variables
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Craving reduction and outcome improvement
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:
IRCT20170924036386N1
Registration date:
2018-01-08, 1396/10/18
Registration timing:
registered_while_recruiting
Last update:
2018-04-24, 1397/02/04
Update count:
1
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Registration date
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2018-01-08, 1396/10/18
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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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Governmental
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Expected recruitment start date
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2017-07-23, 1396/05/01
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Expected recruitment end date
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2018-02-19, 1396/11/30
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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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Comparison of the Effectiveness of LORETA Z Score Neurofeedback with Cognitive Rehabilitation on Decreasing of Craving in Opioid Addicts
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Public title
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Effect of neurofeedback and cognitive rehabilitation in treatment of opium and heroin addicts
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Opium and heroin addicts
Age range: 18-70
Males
Drug use: Methadone
Exclusion criteria:
Age> 70 y/o
Females
Methadone> 100 mg/d
Non opioides addicts
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Age
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From 18 years old to 70 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Table of random numbers
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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No blinding
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Using Neruoguide and Dot Probe software for clinical interventions
Ethics committees
1
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Ethics committee
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Approval date
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2010-09-23, 1389/07/01
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Ethics committee reference number
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IR.ZUMS.REC.1396.97
Health conditions studied
1
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Description of health condition studied
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Opioids Addiction
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ICD-10 code
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ّF11
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ICD-10 code description
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Mental and behavioural disorders due to use of opioids
Primary outcomes
1
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Description
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Craving
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Timepoint
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Begin-mid- end of study
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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ََAddiction Severity Index
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Questionnaire
2
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Description
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Recovery assessment scale
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Questionnaire
3
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Description
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LDQ
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Questionnaire
4
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Description
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Stroop Task
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Questionnaire
5
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Description
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Quality of Life
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Questionnaire
6
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Description
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Anxiety
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Timepoint
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At the beginning, middle and end of the study
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Method of measurement
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Questionnaire
7
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Description
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Depression
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Timepoint
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At the beginning, middle and end of the study
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Method of measurement
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Questionnaire
8
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Description
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Response inhibition
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Questionnaire
9
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Description
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Attention bias
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Cognitive rehabilitation by Dot Probe software. 15 sessions(each session: 20 minute) for everybody in cognitive rehabilitation group will be done in MMT center. Pre and post tests of intervention groups will be compare with pre and post tests of control groups.
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Category
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Rehabilitation
2
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Description
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loreta Neurofeedback therapy.20 sessions and one hour for each session for every body in neurofeedback group will be done in MMT center. Pre and post tests of intervention groups will be compare with pre and post tests of control groups.
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Category
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Other
3
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Description
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Control group:20 members. All pre and post tests of intervention groups will be done for this group for comparing.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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A-11-187-13
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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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Zanjan 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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available