1. Home
  2. Approved trials
  3. » فارسی

The Survey effect of quetiapine on methamphetamine abuse in patients Methadone Maintenance Treatment

View the latest revision

History
# Registration date Revision Id
2 2019-09-19, 1398/06/28 104963
1 2017-11-25, 1396/09/04 27953
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

    60 eligible patients with methamphetamine dependency diagnosis referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
    60 eligible patients with methamphetamine dependency diagnosis referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
    60 بیمار با تشخیص وابستگی به متامفتامین واجد شرایط و ارجاع شده به کلینیک گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
    60 بیمار با تشخیص وابستگی به متامفتامین واجد شرایط و ارجاع شده به کلینیک گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
    Inclusion Criteria are METH dependence; as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV; 18-50 years old and Exclusion Criteria are documented hypersensitivity to quetiapine; severe hepatic impairment; hypertension; seizure disorders and Suicide attempts within the past 12 months
    Inclusion criteria: Aged 18–65 years History of MA and opioid co-abuse in the past year, currently undergoing methadone maintenance treatment, seeking treatment for MA abuse and evaluated by the drug abuse section of the Structured Clinical Interview for DSM-IV and Exclusion Criteria: Suicide attempts within the past 6 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician, current alcohol or sedative physical dependence or cocaine dependence, major cardiovascular disturbance and metabolic diseases (e.g., neurological diseases and diabetes).
    معیارهای ورودبه مطالعه: وابستگي به متامفتامين بر اساس ملاک هاي DSM-IV ؛سن بالاي 18 سال و زير50 سال و معیارهای خروج از مطالعه: سابقه حساسيت شناخته شده نسبت به کوئیتیاپین؛ اختلال شدید کبدی؛ فشار خون بالا؛ اختلالات تشنجی واقدام به خودکشی در 12 ماه گذشته می باشند.
    معیارهای ورود به مطالعه: در محدوده سنی 18 تا 65 سال، سابقه مصرف همزمان اپیوئیدها و متآمفتامین در یکسال گذشته، در حال حاضر تحت درمان نگهدارنده با متادون باشد، به دنبال درمان سوء مصرف متآمفتامین باشد و ارزیابی از طریق راهنمای تشخیصی و آماری اختلال‌های روانی یا DSM‐IV و معیارهای خروج از مطالعه: اقدام به خودکشی در 6 ماه گذشته و یا افکار خودکشی یا علائم روان پریشی در 6 ماه گذشته که توسط یکی از پزشکان مطالعه مشخص شود، در حال حاضر به الکل و یا آرام بخش ها وابستگی جسمی داشته باشد یا به کوکائین معتاد باشد، اختلال عمده قلبی - عروقی و بیماری های متابولیک (به عنوان مثال ، بیماری های عصبی و دیابت).
    The first group will receive quetiapine 25 mg daily for 8 weeks. The second group will receive placebo for 8 weeks.
    The first group will receive quetiapine 100 mg daily for 8 weeks. The second group will receive placebo for 8 weeks.
    گروه اول به مدت 8 هفته روزانه 25 میلی گرم کوئیتیاپین دریافت خواهند کرد.گروه دوم به مدت 8 هفته تحت درمان با دارونما قرار خواهند گرفت .
    گروه اول به مدت 8 هفته روزانه 100 میلی گرم کوئیتیاپین دریافت خواهند کرد.گروه دوم به مدت 8 هفته تحت درمان با دارونما قرار خواهند گرفت .
    Methamphetamine withdrawal symptoms is evaluated with Amphetamine withdrawal questionnaire (AWQ) and Craving is evaluated with VAS and desire of drug questionnaire (DDQ) every fifteen days. Methamphetamine urine test also is done every fifteen days.
    Anxiety, depression, sleep quality, craving, withdrawal and negative urine test for methamphetamine (primary outcomes) and cognitive functions (secondary outcome).
    میزان محرومیت از مت آمفتامین با استفاده از پرسشنامه AWQ، میزان وسوسه با آزمون VASو میزان ولع مصرف با پرسشنامه DDQ بصورت هر 15 روز یک بارارزیابی خواهند گردید. تست ادراری متامفتامین نیز هر 15 روز یک بار به عمل خواهد آمد..
    اضطراب، افسردگی، کیفیت خواب، ولع مصرف، سندرم ترک و منفی شدن متامفتامین ادرار (پیامد اولیه) و عملکردهای شناختی (پیامدهای ثانویه).

  • General information

    50
    65
    1
    2
    3
    60
    empty
    2017-11-22, 1396/09/01
    empty
    2018-01-21, 1396/11/01
    empty
    Inclusion Criteria:18-65 years old; On Methadone maintenance treatment; METH dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV; Seeking treatment for METH use; At least weekly self-reported METH use during a preceding three month period.
    Aged 18–65 years
    History of MA and opioid co-abuse in the past year
    Currently undergoing methadone maintenance treatment
    Seeking treatment for MA abuse
    Evaluated by the drug abuse section of the Structured Clinical Interview for DSM-IV
    معیارهای ورود به مطالعه:18تا50 سال؛ تحت درمان نگهدارنده متادون باشد؛ وابستگی به متآمفتامین، که توسط بخش سوء مصرف مواد از مصاحبه بالینی ساختاریافته برای DSM-V ارزیابی شده است؛ به دنبال درمان مصرف متآمفتامین باشند؛ استفاده ازمتآمفتامین را در طول سه ماه قبل حداقل بصورت هفتگی گزارش کند.
    در محدوده سنی 18 تا 65 سال
    سابقه مصرف همزمان اپیوئیدها و متآمفتامین در یکسال گذشته
    در حال حاضر تحت درمان نگهدارنده با متادون باشد.
    به دنبال درمان سوء مصرف متآمفتامین باشد.
    ارزیابی از طریق راهنمای تشخیصی و آماری اختلال‌های روانی یا DSM‐IV
    Exclusion Criteria: Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician؛ Current opioid, alcohol or sedative physical dependence or cocaine dependence؛ Major cardiovascular disorder؛ present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with quetiapine؛ Metabolic diseases such as diabetes and neurological diseases such as epilepsy
    Suicide attempts within the past 6 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician
    Current alcohol or sedative physical dependence or cocaine dependence
    Major cardiovascular disturbance
    Metabolic diseases (e.g., neurological diseases and diabetes).
    معیارهای خروج از مطالعه: اقدام به خودکشی در 12 ماه گذشته و یا افکار خودکشی یا علائم روان پریشی در 6 ماه گذشته که توسط یکی از پزشکان مطالعه مشخص شود؛ در حال حاضر به الکل و یا آرام بخش ها وابستگی جسمی داشته باشد یا به کوکائین معتاد باشد؛ اختلال قلبی و عروقی عمده؛ استفاده اخیر یا درحال حاضر (در عرض 2 هفته) از داروهایی که انتظار می رود با کوئیتیاپین تداخل داشته باشند؛ بیماری های متابولیک همچون دیابت و بیماری های نورولوژیک همچون صرع
    اقدام به خودکشی در 6 ماه گذشته و یا افکار خودکشی یا علائم روان پریشی در 6 ماه گذشته که توسط یکی از پزشکان مطالعه مشخص شود
    در حال حاضر به الکل و یا آرام بخش ها وابستگی جسمی داشته باشد یا به کوکائین معتاد باشد
    اختلال عمده قلبی - عروقی
    بیماری های متابولیک (به عنوان مثال ، بیماری های عصبی و دیابت).
    Double-blind (both patients and researchers) in your study are blinded.
    Participants, investigators or the assessors of the outcomes are unaware of the study groups.
    دو سوکور (هم بیماران و هم محققان) در مطالعه کور نگه داشته شده اند.
    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.

  • Primary outcomes

    #1
    empty
    Depression
    empty
    افسردگی
    empty
    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Beck Depression Inventory (BDI)
    empty
    پرسشنامه افسردگی بک
    #2
    empty
    Anxiety
    empty
    اضطراب
    empty
    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Beck Anxiety Inventory (BAI)
    empty
    پرسشنامه اضطراب بک
    #3
    empty
    Sleep quality
    empty
    کیفیت خواب
    empty
    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Pittsburgh Sleep Quality Index (PSQI)
    empty
    پرسشنامه کیفیت خواب پترزبورگ
    #4
    empty
    Craving
    empty
    ولع مصرف
    empty
    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Desire for Drug Questionnaire (DDQ craving)
    empty
    پرسشنامه DDQ
    #5
    empty
    Withdrawal
    empty
    سندرم ترک
    empty
    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Amphetamine Withdrawal Questionnaire (AWQ)
    empty
    پرسشنامه AWQ

  • Secondary outcomes

    #1
    Measure of desire for methamphetamine
    Risky Decision Making
    میزان ولع مصرف متامفتامین
    تصمیم گیری ریسکی
    Once every fifteen days
    At the beginning of the study and after 8 weeks of intervention
    هر پانزده روز یکبار
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    by desire for drug questionnaire
    Iowa Gambling Task (IGT)
    پرسشنامه ولع مصرف مواد (DDQ)
    تکلیف قمار آیووا (IGT)
    #2
    Evaluation of methamphetamine withdrawal symptoms
    Memory
    ارزیابی علائم محرومیت متامفتامین
    حافظه
    Once every fifteen days
    At the beginning of the study and after 8 weeks of intervention
    هر پانزده روز یکبار
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    Methamphetamine Withdrawal Questionnaire
    Wechsler Logic Memory
    پرسشنامه محرومیت آمفتامین
    حافظه منطقی وکسلر
    #3
    Evaluation of cognitive function
    Verba Fluency
    ارزیابی عملکرد شناختی
    سیالیت کلامی
    Once every fifteen days
    At the beginning of the study and after 8 weeks of intervention
    هر پانزده روز یکبار
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    Cognitive Function Questionnaire
    FAS task
    پرسشنامه عملکرد شناختی
    آزمون FAS
    #4
    empty
    Speed Processing
    empty
    سرعت پردازش اطلاعات
    empty
    At the beginning of the study and after 8 weeks of intervention
    empty
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    empty
    Digit Symbol and Trial Making Test (TMT)
    empty
    آزمون ایجاد نقش (TMT) و نماد ارقام

  • Intervention groups

    #1
    Intervention group: Quetiapine 40 mg daily for 8 weeks
    Intervention group: Quetiapine 100 mg daily for 8 weeks
    گروه مداخله: کوئیتیاپین 25 میلی گرم در روز به مدت 8 هفته
    گروه مداخله: کوئیتیاپین 100 میلی گرم در روز به مدت 8 هفته

  • 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
Objective: The aim of study is to evaluate the efficacy of quetiapine in treating methamphetamine dependency.
Design
In this research, 60 eligible patients with methamphetamine dependency diagnosis according to DSM-IV criteria are enrolled and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
60 eligible patients with methamphetamine dependency diagnosis referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 18–65 years History of MA and opioid co-abuse in the past year, currently undergoing methadone maintenance treatment, seeking treatment for MA abuse and evaluated by the drug abuse section of the Structured Clinical Interview for DSM-IV and Exclusion Criteria: Suicide attempts within the past 6 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician, current alcohol or sedative physical dependence or cocaine dependence, major cardiovascular disturbance and metabolic diseases (e.g., neurological diseases and diabetes).
Intervention groups
The first group will receive quetiapine 100 mg daily for 8 weeks. The second group will receive placebo for 8 weeks.
Main outcome variables
Anxiety, depression, sleep quality, craving, withdrawal and negative urine test for methamphetamine (primary outcomes) and cognitive functions (secondary outcome).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171106037290N1
Registration date: 2017-11-25, 1396/09/04
Registration timing: retrospective

Last update: 2019-09-24, 1398/07/02
Update count: 1
Registration date
2017-11-25, 1396/09/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 8856
Email address
javdan-na@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-17, 1396/07/25
Expected recruitment end date
2017-11-16, 1396/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Survey effect of quetiapine on methamphetamine abuse in patients Methadone Maintenance Treatment
Public title
Efficacy of quetiapine in methamphetamine dependency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18–65 years History of MA and opioid co-abuse in the past year Currently undergoing methadone maintenance treatment Seeking treatment for MA abuse Evaluated by the drug abuse section of the Structured Clinical Interview for DSM-IV
Exclusion criteria:
Suicide attempts within the past 6 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician Current alcohol or sedative physical dependence or cocaine dependence Major cardiovascular disturbance Metabolic diseases (e.g., neurological diseases and diabetes).
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
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.1396.54

Health conditions studied

1

Description of health condition studied
Methamphetamine dependence
ICD-10 code
F15
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine

Primary outcomes

1

Description
Negative urine test for methamphetamine
Timepoint
Once every fifteen days
Method of measurement
methamphetamine urine test

2

Description
Depression
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Beck Depression Inventory (BDI)

3

Description
Anxiety
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Beck Anxiety Inventory (BAI)

4

Description
Sleep quality
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

5

Description
Craving
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Desire for Drug Questionnaire (DDQ craving)

6

Description
Withdrawal
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Amphetamine Withdrawal Questionnaire (AWQ)

Secondary outcomes

1

Description
Risky Decision Making
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Iowa Gambling Task (IGT)

2

Description
Memory
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Wechsler Logic Memory

3

Description
Verba Fluency
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
FAS task

4

Description
Speed Processing
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Digit Symbol and Trial Making Test (TMT)

Intervention groups

1

Description
Intervention group: Quetiapine 100 mg daily for 8 weeks
Category
Treatment - Drugs

2

Description
Control group: Placebo for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Najmesadat Javdan
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
javdan-na@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Vice chancellor for research, Kashan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Najmesadat Javdan
Position
PHD Assistant in addiction studies
Latest degree
Master
Other areas of specialty/work
Addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
javdan-na@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Position
PhD in Pharmacology-Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5557 9001
Email
banafsh-h@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Najmesadat Javdan
Position
PHD Assistant in addiction studies
Latest degree
Master
Other areas of specialty/work
Addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
javdan-na@kaums.ac.ir

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...