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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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240208060938N1
Enrollment
50
Registered
2024-02-28
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic methamphetamine users. ???????? ????? ? ?????? ???? ?? ???? ???? ?????????

Interventions

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 Sin

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Mahdavi

Kashan University of Medical Sciences

mahdavi.mojtaba.tox@gmail.com+98 84 3222 4777

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026