Protocol summary
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Study aim
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The aim of this study is comparison of the effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving, relapse and mental health in methamphetamine abusers.
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Design
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In this research, 100 eligible patients with methamphetamine dependency diagnosis according to DSM-IV criteria are enrolled and a code was allocated to each one of them. Then, random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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100 eligible patients methamphetamine abuse referred to Farabi Hospital affiliated to Kermanshah University of Medical Sciences, Kermanshah, Iran will be selected in the study. No blind design and factorial.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders.
Exclusion criteria: Unwillingness to cooperate
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Intervention groups
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Patients will be divided into four treatment groups: matrix, methylphenidate, matrix-methylphenidate and control group. The first group (25 people) will be treated individuals, for 22 sessions of 45 minutes, twice a week for three months for matrix treatment. The second group (25 people) will receive methylphenidate 10 mg/day in the first month, 7.5 mg/day in the second month and 5 mg/day in the third month. The third group (25 people) matrix combination with methylphenidate and in the group control (25 people) there is no intervention.
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Main outcome variables
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Addiction severity and craving (primary outcomes)
Mental health and relapse (secondary outcome)
General information
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Reason for update
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The updating process was done before publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171105037245N1
Registration date:
2017-12-09, 1396/09/18
Registration timing:
retrospective
Last update:
2020-07-11, 1399/04/21
Update count:
1
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Registration date
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2017-12-09, 1396/09/18
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-10-14, 1396/07/22
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Expected recruitment end date
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2017-11-13, 1396/08/22
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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 effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving and treatment abstinence in methamphetamine abusers
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Public title
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Comparison of the effect of two therapies methylphenidate and matrix-methylphenidate in methamphetamine abusers
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
being at the age of 20 to 48 years
Methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders fifth edition
The dominant use of methamphetamine
Seeking treatment for methamphetamine abuse
Exclusion criteria:
Unwillingness to participate in the study
Having severe psychotic disorders
Suicide attempts within the past 12 months
Major cardiovascular disorder
Epilepsy
Current alcohol or sedative physical dependence or cocaine dependence
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Age
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From 20 years old to 48 years old
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Gender
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Both
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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:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the 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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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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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-12, 1396/07/20
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Ethics committee reference number
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IR.Kaums.REC.1396.59
Health conditions studied
1
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Description of health condition studied
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Methamphetamine Dependency
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ICD-10 code
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F15.15
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ICD-10 code description
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Other stimulant abuse with stimulant-induced psychotic disorder
Primary outcomes
1
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Description
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Addiction Severity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Addiction Severity Index
2
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Description
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Craving
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Desire for Drug Questionnaire (DDQ craving)
Secondary outcomes
1
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Description
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Mental health
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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General Health Questionnaire (GHQ)
2
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Description
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Negative urine test for methamphetamine
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Timepoint
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Before intervention and 3, 6, 9 and 12 weeks after intervention
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Method of measurement
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Methamphetamine urine test
Intervention groups
1
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Description
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The Matrix program, which consists of 22 sessions of cognitive and behavioral psychotherapy, will be performed weekly in two sessions of forty five minutes for 12 weeks.
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Category
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Behavior
2
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Description
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Methylphenidate ( Ritalin ) will be given 10 mg per day in first month, 7.5 mg per day for second month and 5 mg per day for third month
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Category
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Treatment - Drugs
3
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Description
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Combining matrix and methylphenidate treatment (The Matrix program, which consists of 22 sessions of cognitive and behavioral psychotherapy, will be performed weekly in two sessions of forty five minutes for 12 weeks and methylphenidate ( Ritalin ) will be given 10 mg per day in first month, 7.5 mg per day for second month and 5 mg per day for third month)
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Category
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Treatment - Other
4
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Description
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Control group (not receiving any psychological educational services and drugs)
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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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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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Vice chancellor for research, 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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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