Protocol summary
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Study aim
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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.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients on methadone maintenance treatment and aged 25 to 70 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
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Intervention groups
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Intervention: Patients will be assigned to receive either melatonin (n=30) or placebo (n=30).
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2017-08-17, 1396/05/26
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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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2017-08-03, 1396/05/12
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Expected recruitment end date
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2017-08-21, 1396/05/30
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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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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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Public title
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Effect of melatonin supplementation in treatment of maintenance methadone treatment patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 70 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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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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2017-08-02, 1396/05/11
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Ethics committee reference number
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IR.Kaums.REC.1396.50
Health conditions studied
1
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Description of health condition studied
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Addiction
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ICD-10 code
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F19
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ICD-10 code description
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Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances
Primary outcomes
1
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Description
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Total antioxidant
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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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Spectrophotometry
Secondary outcomes
1
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Description
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HDL
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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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Enzymatic kit
2
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Description
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Total cholesterol
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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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Enzymatic kit
3
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Description
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Triglycerides
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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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Enzymatic kit
4
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Description
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Fasting plasma glucose
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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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Enzymatic kit
5
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Description
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Insulin
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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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Elisa kit
6
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Description
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Nitric oxide
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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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Spectrophotometry
7
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Description
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Hs-CRP
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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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Elisa kit
8
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Description
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Depression beck score
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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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Questionnaire
9
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Description
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Anxiety beck score
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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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Questionnaire
10
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Description
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Expressed levels of LL-1 gene
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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PCR
11
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Description
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Expressed levels of LL-8 gene
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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PCR
12
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Description
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Expressed levels of TNF-a gene
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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PCR
13
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Description
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Expressed levels of PPAR-γ
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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PCR
14
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Description
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Total glutathione
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Spectrophotometry
15
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two oral capsules, one hour before bedtime for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo oral capsule (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks.
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Category
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Treatment - Drugs
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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No - There is not a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available