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IRCT20240208060938N1 IRCT 2024-02-28 Kashan University of Medical Sciences Investigating the effect of nanocurcumin in psychotic methamphetamine users Investigating the effect of nano curcumin supplementation on drug craving, psychotic symptoms and serum levels A2A, TLR4 receptors and TNF-alpha, IL-6 factors in psychotic methamphetamine consuming patients. 2024-04-03 anticipated 50 Complete https://irct.ir/trial/75462 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Supportive, Randomization description: For this purpose, the table of random numbers and block randomization method are used. In this method, 50 eligible patients are randomly divided into 25 blocks including 2 patients. Then, each of the 2 patients in the herbal drug block receives nano curcumin or placebo, so that 25 patients are assigned to each group, Blinding description: The packaging of nano curcumin herbal medicine and placebo is prepared with a label with code B or A. Other specifications on the labels are the same. Researchers, doctors, nurses, patients, those responsible for data collection and those who evaluate the outcome are unaware of the drug and placebo groups. Only the expert responsible for packaging the capsules knows the contents of the packages or the code A or B. Patients are aware that they are either in the herbal medicine group or in the placebo group, but they do not know the type of group they are in. 3 Psychotic methamphetamine users. Intervention 1: Intervention group:In addition to the standard mood stabilizing and antipsychotic drugs, the patients of this group receive two 40 mg nanomicelle curcumin capsules made by Oxirnano Sina twice a day for 4 weeks as a supplement during hospitalization. Intervention 2: Control group: Patients of this group, in addition to mood stabilizers and antipsychotic drugs, two 40 mg capsules of placebo (containing cellulose) with curcumin characteristics in terms of color, shape and other characteristics manufactured by Oxyrnano Sina company twice a day for 4 weeks of intervention. They receive it as a supplement during hospitalization. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mojtaba Mahdavi
Alley shabnam, Javan Street, Mosalli Street
Ilam Iran (Islamic Republic of) 6931475935 +98 84 3222 4777 mahdavi.mojtaba.tox@gmail.com Kashan University of Medical Sciences scientific Amir Ghaderi
Qutb Rawandi Blvd, Doctor's Blvd
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9444 gaderiam@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Being at least 18 years old based on symptoms of methamphetamine psychosis to be admitted to the psychiatric ward. Use of methamphetamine more than two days a week for more than 1 year, as dependent on methamphetamine. Diagnosis of chronic methamphetamine use disorder based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition Based on the diagnosis of the senior research psychiatrist, having the symptoms of methamphetamine psychosis to be admitted to the psychiatric ward, one of the criteria of which is the positive and negative syndrome (PANSS), which was initially created for use in patients with schizophrenia, is one of the most reliable tools to assess the existence and the severity of psychotic symptoms. Having a minimum score of 10 and a maximum score of 70 for drug craving based on the questionnaire measuring the momentary drug craving (DDQ) to enter the intervention. People should not have a history of drug use (opium, opium juice, heroin, crack, and hashish). Completing the consent form. 18 years no limit Both Unwillingness to cooperate at any stage of project implementation. Be dependent on drugs other than methamphetamine. People who are allergic to study and report side effects caused by taking medicine while studying. Taking curcumin and antioxidant and anti-inflammatory supplements in the last 3 months. The urine test for morphine, hashish and other drugs except methamphetamine will be checked three times for each person during the study, and if the test is positive, the patient will be excluded from the study. Pregnant women. Any past or current psychotic disorder, including manic episodes, schizophrenia, and schizoaffective disorder. F10-F19 اختلالات روانی و رفتاری ناشی از مصرف مواد روانگردان Treatment - Drugs Placebo Intervention group:In addition to the standard mood stabilizing and antipsychotic drugs, the patients of this group receive two 40 mg nanomicelle curcumin capsules made by Oxirnano Sina twice a day for 4 weeks as a supplement during hospitalization. Control group: Patients of this group, in addition to mood stabilizers and antipsychotic drugs, two 40 mg capsules of placebo (containing cellulose) with curcumin characteristics in terms of color, shape and other characteristics manufactured by Oxyrnano Sina company twice a day for 4 weeks of intervention. They receive it as a supplement during hospitalization. Methamphetamine dependence and craving score. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study, 4 weeks after taking nanocurcumin and one month later without drug intervention. Method of measurement: Craving score is used to measure craving through visual analog scales (VAS). Serum TNF alpha inflammatory factor. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study after 4 weeks of drug intervention. Method of measurement: To measure serum TNF alpha from the patient's blood serum sample using an ELISA device (immunoassay method) and it is expressed in nanograms per milliliter. Serum IL-6 inflammatory factor. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study after 4 weeks of drug intervention. Method of measurement: To measure serum interleukin 6 from a patient's blood serum sample using an ELISA device (immunoassay method) and it is expressed in nanograms per milliliter. Adenosine A2A receptor (A2A) serum. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study after 4 weeks of drug intervention. Method of measurement: To measure the serum A2A receptor from the patient's blood serum sample using an ELISA device (immunoassay method) and it is expressed in nanograms per milliliter. Toll-like receptor ( TLR4) serum. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study after 4 weeks of drug intervention. Method of measurement: To measure the TLR4 serum receptor from the patient's blood serum sample using an ELISA device (immunoassay method) and it is expressed in nanograms per milliliter. Kashan University of Medical Sciences Approved 2024-01-28 Ethics committee of Kashan University of Medical Sciences Department of Addiction Studies, Faculty of Medicine, Doctor Blvd., Qutb Rawandi Blvd. Kashan Isfehan Iran (Islamic Republic of)