1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving and treatment abstinence in methamphetamine abusers

View the latest revision

History
# Registration date Revision Id
2 2020-07-08, 1399/04/18 142703
1 2017-12-09, 1396/09/18 29158
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    The aim of this study is comparison of the effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving, recurrence and treatment abstinence in methamphetamine abusers.
    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.
    هدف این مطالعه مقایسه تاثیر دو شیوه درمانی متیل فنیدیت و ترکیب ماتریکس- متیل فنیدیت بر شدت اعتیاد، ولع مصرف، عود و ماندگاری درمان در سوء مصرف کنندگان متامفتامین است.
    هدف این مطالعه مقایسه تاثیر دو شیوه درمانی متیل فنیدیت و ترکیب ماتریکس- متیل فنیدیت بر شدت اعتیاد، ولع مصرف، عود و سلامت روان در سوء مصرف کنندگان متامفتامین است.
    Addiction severity (primary outcomes) Craving (secondary outcome)
    Addiction severity and craving (primary outcomes) Mental health and relapse (secondary outcome)
    شدت اعتیاد(پیامدهای اولیه) ولع مصرف(پیامدهای ثانویه)
    ولع مصرف و شدت اعتیاد (پیامدهای اولیه) سلامت روان و عود مجدد (پیامدهای ثانویه)

  • General information

    Factorial
    Parallel
    empty
    The updating process was done before publishing the paper to correct the registration information.
    empty
    پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
    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 for at least 3 months
    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
    محدوده سنی 20 تا 48 سال
    تشخيص وابستگی به متامفتامین برحسب معيارهاي راهنماي تشخيصي و آماري اختلالات رواني نسخه پنجم
    مصرف غالب شيشه حداقل به مدت 3 ماه
    محدوده سنی 20 تا 48 سال
    تشخيص وابستگی به متامفتامین برحسب معيارهاي راهنماي تشخيصي و آماري اختلالات رواني نسخه پنجم
    مصرف غالب شيشه
    به دنبال درمان سوء مصرف متآمفتامین باشد
    Unwillingness to participate in the study
    having severe psychotic disorders
    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
    عدم تمایل به شرکت در مطالعه
    ابتلا به بيماري روانپزشكي شديد
    عدم تمایل به شرکت در مطالعه
    ابتلا به بيماري روانپزشكي شديد
    اقدام به خودکشی در 12 ماه گذشته
    اختلال عمده قلبی و عروقی
    تشنج
    در حال حاضر به الکل و یا آرام بخش ها وابستگی جسمی داشته باشد یا به کوکائین معتاد باشد
    Random assignment will be done by the use of computer-generated random numbers.
    Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers.
    تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
    نحوه تصادفی سازی با روش ساده و استفاده از اعداد تصادفی ایجاد شده توسط نرم افزار کامپیوتری (نرم افزار Stat Trek) انجام خواهد شد. در اين روش كامپيوتر اعداد تصادفي انتخاب مي كند.
    empty
    empty
    empty
    empty

  • Primary outcomes

    #1
    Before intervention and 4, 8 and 12 weeks after intervention
    At the beginning of the study and after 12 weeks of intervention
    قبل از مداخله و 4، 8 و 12هفته بعد از شروع مداخله
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    شاخص شدت اعتیاد (ASI)
    شاخص شدت اعتیاد
    #2
    empty
    Craving
    empty
    ولع مصرف
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Desire for Drug Questionnaire (DDQ craving)
    empty
    پرسشنامه DDQ

  • Secondary outcomes

    #1
    Craving
    Mental health
    ولع مصرف
    سلامت روان
    Before intervention and 4, 8 and 12 weeks after intervention
    At the beginning of the study and after 12 weeks of intervention
    قبل از مداخله و 4، 8 و 12هفته بعد از شروع مداخله
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    Visual cues inducing craving
    General Health Questionnaire (GHQ)
    آزمون تصويري سنجش ولع مصرف (Visual cues inducing craving )
    پرسشنامه سلامت عمومی (GHQ)
    #2
    empty
    Negative urine test for methamphetamine
    empty
    منفی شدن متامفتامین ادرار
    empty
    Before intervention and 3, 6, 9 and 12 weeks after intervention
    empty
    قبل از مداخله و 3، 6، 9 و 12هفته بعد از شروع مداخله
    empty
    Methamphetamine urine test
    empty
    تست سریع ادراری

  • Recruitment centers

    #1
    Name of recruitment center - English: Faraby Hospital Substance Dependency Clinic
    Name of recruitment center - Persian: درمانگاه اعتیاد بیمارستان فارابی
    Full name of responsible person - English: Nazanine Arian
    Full name of responsible person - Persian: نازنین آرین
    Street address - English: Isar square, Farabi hospital, Kermanshah
    Street address - Persian: کرمانشاه، بلوار ایثار، بیمارستان فارابی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Faraby Hospital Substance Dependency Clinic
    Name of recruitment center - Persian: درمانگاه اعتیاد بیمارستان فارابی
    Full name of responsible person - English: Nazanine Arian
    Full name of responsible person - Persian: نازنین آرین
    Street address - English: First floor, No. 7, Farabi Hospital, Isar Blvd., Kermanshah
    Street address - Persian: کرمانشاه، بلوار ایثار، بیمارستان فارابی، پلاک7، طبقه اول
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6719851451
    Phone: +98 83 3826 4513
    Fax:
    Email: arian-n@kaums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988171
    Phone: +98 31 5554 2999
    Fax:
    Email: hamidi_gh@kaums.ac.ir
    Web page address:

  • Sharing plan

    empty
    Undecided - It is not yet known if there will be a plan to make this available
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders. Exclusion criteria: Unwillingness to cooperate
Intervention groups
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.
Main outcome variables
Addiction severity and craving (primary outcomes) Mental health and relapse (secondary outcome)

General information

Reason for update
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
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
Registration date
2017-12-09, 1396/09/18
Registrant information
Name
Nazanin Arian
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 4513
Email address
arian-n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-10-14, 1396/07/22
Expected recruitment end date
2017-11-13, 1396/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two therapies methylphenidate and matrix-methylphenidate on the severity of addiction, craving and treatment abstinence in methamphetamine abusers
Public title
Comparison of the effect of two therapies methylphenidate and matrix-methylphenidate in methamphetamine abusers
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 48 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.Kaums.REC.1396.59

Health conditions studied

1

Description of health condition studied
Methamphetamine Dependency
ICD-10 code
F15.15
ICD-10 code description
Other stimulant abuse with stimulant-induced psychotic disorder

Primary outcomes

1

Description
Addiction Severity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Addiction Severity Index

2

Description
Craving
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Desire for Drug Questionnaire (DDQ craving)

Secondary outcomes

1

Description
Mental health
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
General Health Questionnaire (GHQ)

2

Description
Negative urine test for methamphetamine
Timepoint
Before intervention and 3, 6, 9 and 12 weeks after intervention
Method of measurement
Methamphetamine urine test

Intervention groups

1

Description
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.
Category
Behavior

2

Description
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
Category
Treatment - Drugs

3

Description
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)
Category
Treatment - Other

4

Description
Control group (not receiving any psychological educational services and drugs)
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Faraby Hospital Substance Dependency Clinic
Full name of responsible person
Nazanine Arian
Street address
First floor, No. 7, Farabi Hospital, Isar Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851451
Phone
+98 83 3826 4513
Email
arian-n@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988171
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
PhD of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
Email
omidi-a@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
PhD of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
Email
omidi-a@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Omidi
Position
PhD of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ghotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
Email
omidi-a@kums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...