A Clinical trial to assess the effect of melatonin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients
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Protocol summary
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Inclusion criteria: Patients on methadone maintenance treatment and aged 25 to 70 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Inclusion criteria: Patients on methadone maintenance treatment and aged 1825 to 6070 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
معیار ورود به مطالعه: بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 18 تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد.
معیار ورود به مطالعه: بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 25 تا 70 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد.
معیار ورود به مطالعه: بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 1825 تا 6070 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد.
General information
18
25
1825
60
70
6070
1
1
Patients on maintenance methadone treatment
Age of 18 to 60 years
Patients on maintenance methadone treatment
Age of 25 to 70 years
Patients on maintenance methadone treatment Age of 1825 to 6070 years
بیماران تحت درمان نگهدارنده با متادون
محدوده سنی 18 تا 60 سال
بیماران تحت درمان نگهدارنده با متادون
محدوده سنی 25 تا 70 سال
بیماران تحت درمان نگهدارنده با متادون محدوده سنی 1825 تا 6070 سال
Unwillingness to cooperate
Taking melatonin, multivitamin-mineral and antioxidant supplements during the last 3 months before the intervention
Taking anti-inflammatory agents
History of metabolic diseases including diabetes, hypertension, thyroid and cardiovascular disease
Unwillingness to cooperateTaking melatonin, multivitamin-mineral and antioxidant supplements during the last 3 months before the intervention Taking anti-inflammatory agents History of metabolic diseases including diabetes, hypertension, thyroid and cardiovascular disease
عدم تمایل به همکاری
گرفتن مکمل های ملاتونین، مولتی ویتامین-مینرال و آنتی اکسیدانت در طی سه ماه قبل از مداخله
گرفتن داروهای ضد التهابی
سابقه بیماری متابولیک از قبیل دیابت، فشار خون، تیروئید و بیماری قلبی عروقی
عدم تمایل به همکاریگرفتن مکمل های ملاتونین، مولتی ویتامین-مینرال و آنتی اکسیدانت در طی سه ماه قبل از مداخله گرفتن داروهای ضد التهابی سابقه بیماری متابولیک از قبیل دیابت، فشار خون، تیروئید و بیماری قلبی عروقی
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Protocol summary
Study aim
The aim of this study is to determine the effects of melatonin supplementation on mental health parameters, metabolic profiles and genetic response 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 Gholabchi 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 25 to 70 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention: Patients will be assigned to receive either melatonin (n=30) or placebo (n=30).
Main outcome variables
Total antioxidant (primary outcome), other metabolic profiles, mental health parameters and genetic response (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017072933551N3
Registration date:2017-08-17, 1396/05/26
Registration timing:registered_while_recruiting
Last update:2019-09-15, 1398/06/24
Update count:2
Registration date
2017-08-17, 1396/05/26
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
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-08-03, 1396/05/12
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to assess the effect of melatonin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients
Public title
Effect of melatonin supplementation in treatment of maintenance methadone treatment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients on maintenance methadone treatment
Age of 25 to 70 years
Exclusion criteria:
Taking melatonin, multivitamin-mineral and antioxidant supplements during the last 3 months before the intervention
Taking anti-inflammatory agents
History of metabolic diseases including diabetes, hypertension, thyroid and cardiovascular disease
Age
From 25 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
2017-08-02, 1396/05/11
Ethics committee reference number
IR.Kaums.REC.1396.50
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances
Primary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
6
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
8
Description
Depression beck score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
9
Description
Anxiety beck score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
10
Description
Expressed levels of LL-1 gene
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
11
Description
Expressed levels of LL-8 gene
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
12
Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
13
Description
Expressed levels of PPAR-γ
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
14
Description
Total glutathione
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Spectrophotometry
15
Description
Malondialdehyde
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two oral capsules, one hour before bedtime for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo oral capsule (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5544 0022
Email
asemi_r@yahoo.com
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
8814187159
Phone
+98 31 5554 2999
Email
hamidi.gholamali2@gmail.com
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
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.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
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.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
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD