Protocol summary
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Study aim
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Evaluation of The Effect of Melatonin Supplementation on Mental Health, Stem Cells Mobilization and central nervous system function among Methamphetamine Users: Behavioral, Biochemical Evaluation
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Design
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The clinical trial has an intervention group and a control group. Samples are divided into groups using block randomization method.
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Settings and conduct
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This investigation designed to determine the effect of melatonin supplementation on mental health parameters, metabolic and genetic profiles in patients with Methamphetamine Abuse Disorder.
In this Study, Participants are randomly allocated divide into two groups (intervention and control).
for the intervention group, Participants receive either 10 mg melatonin (2 melatonin capsules, 5 mg each)once a day 1 hour before bedtime for 4 weeks.
In this study, evaluators and analyzers are blinded to groups.
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Participants/Inclusion and exclusion criteria
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Male؛ be aged between 18 and 55؛ methamphetamine dependence؛ have a methamphetamine use history longer than 12 months;
No an intellectual disability؛ No psychiatric illness؛ No current medical illness
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Intervention groups
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In This Study for the intervention group, Participants receive either 10 mg melatonin (2 melatonin capsules, 5 mg each)once a day 1 hour before bedtime for 4 weeks. The subjects in the control group were evaluated without receiving melatonin during the same period.
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Main outcome variables
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Assessing the amount of Mobilization of Hematopoietic Stem Cells in the Plasma; Quality of Sleep; Depression Rate; Anxiety Rate; Evaluation of Brain-Derived Neurotrophic Factor
General information
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Reason for update
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Examining some factors that can be helpful in examining the possible outcome of the study and possible results.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200521047533N1
Registration date:
2021-05-24, 1400/03/03
Registration timing:
registered_while_recruiting
Last update:
2022-07-31, 1401/05/09
Update count:
1
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Registration date
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2021-05-24, 1400/03/03
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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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2021-05-22, 1400/03/01
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Expected recruitment end date
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2022-07-22, 1401/04/31
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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 Melatonin Supplementation on Mental Health, Stem Cells Mobilization and central nervous system function among Methamphetamine Users: Behavioral, Biochemical
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Public title
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The effect of melatonin on the side effects of methamphetamine
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
have a methamphetamine use history longer than 12 months;
Male
No history of severe Neurological disease
No history of severe Head Trauma
Do not take psychiatric drugs now
Exclusion criteria:
Having severe psychological illness
Having blood diseases
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Age
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From 18 years old to 55 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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No information
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, Permuted block randomization is used.
I. Randomization type, details of any restrictions (such as blocking and block size)
Because patients gradually enter the study and the 4-volume block method is used to make the sample size the same in the two groups. For this purpose, 6 quadruple blocks will be created as follows
1-AABB
2- ABAB
3-ABBA
4-BBAA
5-BABA
6-BAAB
Where A is for the intervention group and B is for the control group. The random assignment will be done in such a way that first a random number will be created in Excel from 0 to 9. Depending on which block the random number belongs to, the sequence of that block will be used to assign patients to the control and intervention groups. For example, if the random number generated is 6, the first person will be assigned to group B, the second person to group A, the third person to group A, and the fourth person to group B. To reach the calculated sample size, the random number creation will be repeated 12 times. Because each time the repetition task is assigned, four patients are identified (56 random sequences, each group of 28 people will be produced taking into account the drop). It should be noted that if the random number generated is 7, 8, 9 and 0, it will be ignored.
II. Participant allocation concealment method (mechanism used to randomize participant allocation (such as consecutive numbered containers) and explain all the steps that can be taken to hide the sequence until the intervention is assigned to each group)
Envelopes in which the specified group is placed are used to conceal the allocation. Envelopes are numbered. After filling in the basic information of the people, an envelope is opened according to the order of entry of the people and the person is assigned to the desired group. That is, 56 envelopes of one shape will be prepared based on the order of A and B above and will be numbered from 1 to 56, respectively.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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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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2021-02-07, 1399/11/19
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Ethics committee reference number
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IR.SHMU.REC.1399.173
Health conditions studied
1
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Description of health condition studied
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Methamphetamine Addiction
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ICD-10 code
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F15.1
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ICD-10 code description
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Other stimulant abuse
Primary outcomes
1
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Description
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Evaluation of percentage of circulating stem cells in the blood by measuring CD + 34 and CD45 markers
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Timepoint
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Pre and Post Treatment
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Method of measurement
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Flow cytometry
Secondary outcomes
1
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Description
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Sleep Quality
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Pittsburgh Sleep Quality Index
2
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Description
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Evaluation of patients' depression
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Beck Depression Inventory
3
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Description
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Evaluation of patients' anxiety
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Beck Anxiety Inventory
4
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Description
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Brain-derived neurotrophic factor (BDNF)
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Enzyme-linked Immunosorbent Assay (ELISA) kites
5
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Description
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Glial fibrillary acidic protein (GFAP)
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Enzyme-linked Immunosorbent Assay (ELISA) kites
6
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Description
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measures brain activity by Functional magnetic resonance imaging(fMRI)
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Using Functional magnetic resonance imaging(fMRI)
7
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Description
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Anatomical study of white matter fibers
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Using Diffusion tensor imaging (DTI)
8
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Description
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Investigating changes in Cognitive and functional brain factors such as memory and executive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB)
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Timepoint
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Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment)
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Method of measurement
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Using the Cambridge Neuropsychological Test Automated Battery(CANTAB)
Intervention groups
1
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Description
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Intervention group: Participants receive either 10 mg melatonin (2 melatonin capsules, 5 mg each)once a day 1 hour before bedtime for 4 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Participants in this group did not receive any medication for 4 weeks due to this study.
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Category
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N/A
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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Shahroud 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is 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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Not applicable
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Title and more details about the data/document
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Because this project is my graduate dissertation, the results can be published in the dissertation as well as scientific articles and made available to the public.
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When the data will become available and for how long
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6 months after the publication of dissertations and articles
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To whom data/document is available
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Scientific research centers and addiction therapists
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Under which criteria data/document could be used
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Use of data along with mentioning the name of the data collection source and the main researchers
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From where data/document is obtainable
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By email and communication with the scientific director of the project
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What processes are involved for a request to access data/document
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After receiving the applicant's email and reviewing it within a maximum of 2 months
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Comments
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