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The effect of crocin supplementation on cognitive functions, craving and withdrawal syndrome in methadone maintenance treatment patients

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History
# Registration date Revision Id
2 2020-07-14, 1399/04/24 143233
1 2019-07-09, 1398/04/18 96150
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  • Protocol summary

    Population and sample size: 60 eligible patients on methadone maintenance treatment referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study
    Population and sample size: 60 eligible patients on methadone maintenance treatment referred to Soltan Mirahmad Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study
    حجم نمونه و جمعیت مورد مطالعه: 60 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
    حجم نمونه و جمعیت مورد مطالعه: 60 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک سلطان میراحمد وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
    Mental health parameters (primary outcome), cognitive functions, craving and withdrawal syndrome (secondary outcome) will be quantified at study baseline and end-of-trial.
    Craving and withdrawal syndrome (primary outcome), and cognitive functions (secondary outcome) will be quantified at study baseline and end-of-trial.
    پارامترهای سلامت روان (پیامد اولیه)، عملکردهای شناختی، ولع مصرف و علائم سندرم ترک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
    ولع مصرف و علائم سندرم ترک (پیامد اولیه) و عملکردهای شناختی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    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.
    Patients on methadone maintenance treatment
    Age of 18 to 70 years old
    Patients on methadone maintenance treatment
    Age of 18 to 70 years old
    Evaluated by the drug abuse section of the Structured Clinical Interview for DSM‐IV
    Seeking for treatment
    بیماران تحت درمان نگهدارنده با متادون
    محدوده سنی 18 تا 70 سال
    بیماران تحت درمان نگهدارنده با متادون
    محدوده سنی 18 تا 70 سال
    ارزیابی از طریق راهنمای تشخیصی و آماری اختلال‌های روانی یا DSM‐IV
    به دنبال درمان باشد
    Unwillingness to cooperate
    Current severe depression and mania
    Psychosis
    Unwillingness to cooperate
    Current severe depression and mania
    Psychosis
    Consumption of crocin, antioxidant, and anti-inflammatory supplements during the last 3 months
    High blood pressure
    Hypothyroidism or hyperthyroidism
    عدم تمایل به همکاری
    دوره اخیر افسردگی و مانیا
    سایکوز
    عدم تمایل به همکاری
    دوره اخیر افسردگی و مانیا
    سایکوز
    مصرف مکمل های کروسین، ضد التهابی و آنتی اکسیدان در طول 3 ماه گذشته
    فشار خون بالا
    کم کاری تیروئید یا پرکاری تیروئید

  • Primary outcomes

    #1
    Depression beck score
    Craving
    امتیاز بک افسردگی
    ولع مصرف
    Questionnaire
    Desire for Drug Questionnaire (DDQ craving)
    پرسشنامه
    پرسشنامه DDQ
    #2
    Anxiety beck score
    Withdrawal syndrome
    امتیاز بک اضطراب
    سندرم ترک
    Questionnaire
    Clinical opiate withdrawal symptoms (COWS)
    پرسشنامه
    پرسشنامه COWS
    #3
    Sleep quality
    empty
    کیفیت خواب
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire(PSQI)
    empty
    پرسشنامه (PSQI)
    empty

  • Secondary outcomes

    #1
    Attention
    Verba Fluency
    توجه
    سیالیت کلامی
    در ابتدای مطالعه و بعد از مداخله (12 هفته)
    در ابتدای مطالعه و بعد از مداخله (12هفته)
    Continuous performance task (CPT)
    FAS task
    تکلیف عملکرد مداوم (CPT)
    آزمون FAS
    #2
    Risky Decision Making
    Speed Processing
    تصمیم گیری ریسکی
    سرعت پردازش اطلاعات
    Iowa Gambling Task (IGT)
    Digit Symbol and Trial Making Test (TMT)
    تکلیف قمار آیووا (IGT)
    آزمون ایجاد نقش (TMT) و نماد ارقام
    #3
    Verba Fluency
    Memory
    سیالیت کلامی
    حافظه
    FAS task
    Wechsler intelligence Scale (DGSP)
    آزمون FAS
    حافظه منطقی وکسلر (DGSP)
    #4
    Speed Processing
    empty
    سرعت پردازش اطلاعات
    empty
    At the baseline and after intervention (12 weeks)
    empty
    در ابتدای مطالعه و بعد از مداخله (12هفته)
    empty
    Digit Symbol and Trial Making Test (TMT)
    empty
    آزمون ایجاد نقش (TMT) و نماد ارقام
    empty
    #5
    Craving
    empty
    ولع مصرف
    empty
    At the baseline and after intervention (12 weeks)
    empty
    در ابتدای مطالعه و بعد از مداخله (12هفته)
    empty
    Craving questionnaire
    empty
    پرسشنامه ولع مصرف
    empty
    #6
    Withdrawal syndrome
    empty
    سندرم ترک
    empty
    At the baseline and after intervention (12 weeks)
    empty
    در ابتدای مطالعه و بعد از مداخله (12هفته)
    empty
    Withdrawal syndrome questionnaire
    empty
    پرسشنامه سندرم ترک
    empty

  • Recruitment centers

    #1
    Name of recruitment center - English: Gholabchi Clinic
    Name of recruitment center - Persian: کلینیک گلابچی
    Full name of responsible person - English: Hamid Reza Banafshe
    Full name of responsible person - Persian: حمیدرضا بنفشه
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8814187159
    Phone: +98 31 4455 2200
    Fax:
    Email: banafshe57@hotmail.com
    Web page address:
    Name of recruitment center - English: Soltan Mirahmad Clinic
    Name of recruitment center - Persian: کلینیک سلطان میراحمد
    Full name of responsible person - English: Amir Ghaderi
    Full name of responsible person - Persian: امیرقادری
    Street address - English: Shahid Motahari Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید مطهری
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8814187159
    Phone: +98 31 5554 6769
    Fax:
    Email: gaderiam@yahoo.com
    Web page address:

Protocol summary

Study aim
The aim of this study is to determine the effects of crocin supplementation on cognitive functions, craving and withdrawal syndrome in methadone maintenance treatment patients
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: 60 eligible patients on methadone maintenance treatment referred to Soltan Mirahmad Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 70 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention: Patients will be assigned to receive either crocin (n=30) or placebo (n=30).
Main outcome variables
Craving and withdrawal syndrome (primary outcome), and cognitive functions (secondary outcome) will be quantified at study baseline and end-of-trial.

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: IRCT20170420033551N6
Registration date: 2019-07-09, 1398/04/18
Registration timing: retrospective

Last update: 2020-07-15, 1399/04/25
Update count: 1
Registration date
2019-07-09, 1398/04/18
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-19, 1398/02/29
Expected recruitment end date
2019-06-19, 1398/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of crocin supplementation on cognitive functions, craving and withdrawal syndrome in methadone maintenance treatment patients
Public title
Effect of crocin supplementation in treatment of methadone maintenance treatment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients on methadone maintenance treatment Age of 18 to 70 years old Evaluated by the drug abuse section of the Structured Clinical Interview for DSM‐IV Seeking for treatment
Exclusion criteria:
Unwillingness to cooperate Current severe depression and mania Psychosis Consumption of crocin, antioxidant, and anti-inflammatory supplements during the last 3 months High blood pressure Hypothyroidism or hyperthyroidism
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<40 and ≥40 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
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
8814187159
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.012

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders

Primary outcomes

1

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

2

Description
Withdrawal syndrome
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Clinical opiate withdrawal symptoms (COWS)

Secondary outcomes

1

Description
Evaluation of cognitive function
Timepoint
At the baseline and after intervention (12 weeks)
Method of measurement
Cognitive function questionnaire

2

Description
Verba Fluency
Timepoint
At the baseline and after intervention (12 weeks)
Method of measurement
FAS task

3

Description
Speed Processing
Timepoint
At the baseline and after intervention (12 weeks)
Method of measurement
Digit Symbol and Trial Making Test (TMT)

4

Description
Memory
Timepoint
At the baseline and after intervention (12 weeks)
Method of measurement
Wechsler intelligence Scale (DGSP)

Intervention groups

1

Description
Intervention group: tablet of crocin, 15 mg, two oral tablet for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: placebo tablet, two oral tablet for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Soltan Mirahmad Clinic
Full name of responsible person
Amir Ghaderi
Street address
Shahid Motahari Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 6769
Email
gaderiam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Grant name
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
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
gaderiam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
gaderiam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Email
gaderiam@yahoo.com

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
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