Protocol summary

Study aim
Determination of the effectiveness of nano curcumin supplement on drug craving, psychotic symptoms and serum levels of pro-inflammatory factors and A2A, TLR4 receptors in psychotic methamphetamine consuming patients
Design
This clinical trial has a control group in a double-blind, randomized phase 3 method on 50 psychotic methamphetamine patients in two groups, where randomization is done by block method.
Settings and conduct
A study with the design of a controlled clinical trial - double-blind placebo treatment on 50 psychotic methamphetamine consuming patients referred to Kashan Psychiatric Hospital who were admitted and then randomly divided into two groups. Researchers and participants are unaware of the drug and placebo groups. Nanocurcumin capsule drug or placebo with identification code A or B is prescribed for 4 weeks. Blood samples will be taken at the beginning of the study and 4 weeks after the intervention of the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: completion of the consent form; having symptoms of methamphetamine psychosis with the diagnosis of the senior research psychiatrist for hospitalization; Having a craving score between 10 and 70 based on a momentary measurement questionnaire to enter the intervention. Exclusion criteria: unwillingness to cooperate in any stage of project implementation; People who are allergic to drugs during the study; any past or present psychotic disorder; pregnant women.
Intervention groups
Study patients are randomly divided to receive nanocurcumin supplement 40 mg twice a day (N=25) or placebo (N=25) orally for a period of 4 weeks.
Main outcome variables
Craving score and recovery of psychotic symptoms of patients; Inflammatory factor TNF alpha; inflammatory factor IL-6; Determination of serum A2A and TLR4 receptors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240208060938N1
Registration date: 2024-02-28, 1402/12/09
Registration timing: prospective

Last update: 2024-02-28, 1402/12/09
Update count: 0
Registration date
2024-02-28, 1402/12/09
Registrant information
Name
Mojtaba Mahdavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 4777
Email address
mahdavi.mojtaba.tox@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Investigating the effect of nanocurcumin in psychotic methamphetamine users
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Department of Addiction Studies, Faculty of Medicine, Doctor Blvd., Qutb Rawandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2024-01-28, 1402/11/08
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.258

Health conditions studied

1

Description of health condition studied
Psychotic methamphetamine users
ICD-10 code
F10-F19
ICD-10 code description
اختلالات روانی و رفتاری ناشی از مصرف مواد روانگردان

Primary outcomes

1

Description
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).

Secondary outcomes

1

Description
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.

2

Description
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.

3

Description
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.

4

Description
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.

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Karganjad Hospital, Kashan University of Medical Sciences
Full name of responsible person
Mojtaba Mahdavi
Street address
Karganjad hospital, end of Nurse Blvd., Qutb Ravandi Blvd.,
City
Kashan
Province
Isfehan
Postal code
۸۷۱۵۹۷۳۴۴۶
Phone
+98 918 843 3034
Fax
+98 31 5588 1124
Email
mahdavi.mojtaba.tox@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
5th kilometer of Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mojtaba Mahdavi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Toxicology
Street address
Alley shabnam, Javan Street, Mosalli Street
City
Ilam
Province
Ilam
Postal code
6931475935
Phone
+98 84 3222 4777
Email
mahdavi.mojtaba.tox@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Qutb Rawandi Blvd, Doctor's Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5558 9444
Email
gaderiam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mojtaba Mahdavi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Toxicology
Street address
Alley Shabnam, Javan Street, Mosalli Street
City
Ilam
Province
Ilam
Postal code
6931475935
Phone
+98 84 3222 4777
Email
mahdavi.mojtaba.tox@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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