Protocol summary
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Study aim
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The aim of this study is to determine the effects of crocin supplementation on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients
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Design
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Clinical trial with control group, parallel groups, double-blind (both patients and researchers), randomized, 60 patients, phase 2
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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 18 to 60 years, Beck Depression Scores > 20 and Beck Anxiety > 15 will be included in this study. Exclusion criteria: Taking crocin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention, history of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.
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Intervention groups
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Intervention: Patients will be assigned to receive either crocin (n=30) or placebo (n=30).
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Main outcome variables
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Mental health parameters (primary outcome), metabolic profiles and genetic response (secondary outcome)
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:
IRCT20170420033551N4
Registration date:
2018-12-31, 1397/10/10
Registration timing:
registered_while_recruiting
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2018-12-31, 1397/10/10
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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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Expected recruitment start date
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2018-12-13, 1397/09/22
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Expected recruitment end date
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2019-01-12, 1397/10/22
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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 crocin 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 crocin supplementation in treatment of methadone maintenance 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:
Currently undergoing MMT and opioid dependence in the past year
Age of 18 to 60 years old
Evaluated by the drug abuse section of the Structured Clinical Interview for DSM‐IV
Beck Depression Scores > 20 and Beck Anxiety > 15
Seeking for treatment
Exclusion criteria:
Taking crocin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention.
History of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.
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Age
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From 18 years old to 60 years old
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Gender
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Male
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Phase
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2
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Groups that have been masked
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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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Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups. .
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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 will be used to achieve participants and investigators masking. 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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2018-12-11, 1397/09/20
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Ethics committee reference number
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IR.KAUMS.REC.1397.006
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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Depression beck score
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Questionnaire
2
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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 8 weeks of intervention
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Method of measurement
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Questionnaire
Secondary 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 8 weeks of intervention
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Method of measurement
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Spectrophotometry
2
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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 8 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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Total cholesterol
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Timepoint
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At the beginning of the study and after 8 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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Triglycerides
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Timepoint
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At the beginning of the study and after 8 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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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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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 8 weeks of intervention
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Method of measurement
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Elisa kit
7
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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 8 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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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 8 weeks of intervention
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Method of measurement
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Elisa kit
9
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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 8 weeks after intervention
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Method of measurement
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PCR
10
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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 8 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 PPAR-γ
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Timepoint
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At the beginning of the study and 8 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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Total glutathione
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Timepoint
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At the beginning of the study and 8 weeks after intervention
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Method of measurement
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Spectrophotometry
13
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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 8 weeks after intervention
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Method of measurement
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Spectrophotometry
14
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Description
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Expressed levels of TGF-β gene
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Timepoint
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At the beginning of the study and 8 weeks after intervention
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Method of measurement
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PCR
15
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Description
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Expressed levels of LDLR gene
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Timepoint
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At the beginning of the study and 8 weeks after intervention
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Method of measurement
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PCR
Intervention groups
1
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Description
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Intervention group: tablet of Crocin, 15 mg, two oral tablet for 8 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 tablet, two oral tablet for 8 weeks.
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Category
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Placebo
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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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