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 cognitive functions, craving and withdrawal syndrome 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 Soltan Mirahmad 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 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 crocin (n=30) or placebo (n=30).
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Main outcome variables
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Craving and withdrawal syndrome (primary outcome), and cognitive functions (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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The updating process was done before publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-07-09, 1398/04/18
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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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2019-05-19, 1398/02/29
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Expected recruitment end date
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2019-06-19, 1398/03/29
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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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The effect of crocin supplementation on cognitive functions, craving and withdrawal syndrome 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:
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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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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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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.
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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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2019-04-08, 1398/01/19
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1398.012
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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Other psychoactive substance related disorders
Primary outcomes
1
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Description
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Craving
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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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Desire for Drug Questionnaire (DDQ craving)
2
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Description
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Withdrawal syndrome
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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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Clinical opiate withdrawal symptoms (COWS)
Secondary outcomes
1
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Description
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Evaluation of cognitive function
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Timepoint
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At the baseline and after intervention (12 weeks)
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Method of measurement
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Cognitive function questionnaire
2
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Description
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Verba Fluency
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Timepoint
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At the baseline and after intervention (12 weeks)
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Method of measurement
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FAS task
3
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Description
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Speed Processing
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Timepoint
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At the baseline and after intervention (12 weeks)
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Method of measurement
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Digit Symbol and Trial Making Test (TMT)
4
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Description
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Memory
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Timepoint
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At the baseline and after intervention (12 weeks)
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Method of measurement
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Wechsler intelligence Scale (DGSP)
Intervention groups
1
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Description
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Intervention group: tablet of crocin, 15 mg, two oral tablet 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 tablet, two oral tablet for 12 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available