Blood levels of LRFN5 and OLFM4 in methamphetamine users with and without psychosis
Serum LRFN5 and OLFM4 Levels in Methamphetamine Use Disorder and Methamphetamine-Induced Psychotic Disorder: A Cross-Sectional Case-Control Study
This project will test whether blood levels of two proteins, LRFN5 and OLFM4, differ between adults with methamphetamine use disorder, adults who develop methamphetamine-induced psychosis, and healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Male |
| Sponsor | Elazığ Mental Health and Diseases Hospital Government |
| Locations | 1 site (Elâzığ, Elâzığ) |
| Trial ID | NCT07450027 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional, case-control study comparing serum LRFN5 and OLFM4 levels in three groups: participants with methamphetamine use disorder (MUD), participants with methamphetamine-induced psychotic disorder (MP), and healthy controls. Researchers will also measure systemic inflammation using the Aggregate Index of Systemic Inflammation (AISI) and relate biomarker levels to clinical symptom scores on the Positive and Negative Syndrome Scale (PANSS) and the Insight Assessment Scale (IAS). Participants are medication-free for at least one month, aged 18–65, and recruited at a single site. Blood samples and clinical ratings will be collected once per participant for between-group comparisons and correlation analyses.
Who should consider this trial
Good fit: Adults aged 18–65 who meet DSM-5-TR criteria for methamphetamine use disorder or methamphetamine-induced psychotic disorder, are medication-free for at least one month, can give informed consent, and do not have major systemic or immune illnesses are ideal candidates (healthy adults are eligible as controls).
Not a fit: People with excluded medical conditions (for example hypertension, diabetes, chronic kidney disease, autoimmune disorders), primary psychiatric disorders other than MUD/MP, active alcohol use disorder, or who cannot travel to the study site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If these proteins are linked to psychosis risk or severity, they could help identify methamphetamine users at higher risk of psychosis and inform earlier monitoring or interventions.
How similar studies have performed: LRFN5 and OLFM4 have not been studied previously in methamphetamine use or related psychosis, so this is a novel biomarker approach, while other neuroinflammatory marker studies in substance-related psychosis have produced mixed preliminary results.
Eligibility criteria
Show full inclusion / exclusion criteria
1. For Methamphetamine Use Disorder (MUD) Group: \*Inclusion Criteria: * Diagnosis of MUD according to DSM-5-TR * Medication-free for at least one month prior to admission * Age ≥ 18 years and \<65 years * Provided informed consent For Methamphetamine Use Disorder (MUD) Group: \*Exclusion Criteria: • Hypertension * Diabetes mellitus * Chronic kidney disease * Rheumatoid arthritis * Systemic lupus erythematosus * Cardiac illness * Severe neurological disorders * Immunological or systemic illness * Primary psychiatric disorders other than MUD * Alcohol use disorder 2. For Methamphetamine-Induced Psychotic Disorder (MP) Group: \*Inclusion Criteria: * Diagnosis of MP according to DSM-5-TR * Medication-free for at least one month prior to admission * Age ≥ 18 years and \<65 years * Provided informed consent For Methamphetamine-Induced Psychotic Disorder (MP) Group: \*Exclusion Criteria: * Hypertension * Diabetes mellitus * Chronic kidney disease * Rheumatoid arthritis * Systemic lupus erythematosus * Cardiac illness * Severe neurological disorders * Immunological or systemic illness * Primary psychiatric disorders other than MP * Alcohol use disorder 3. For Healthy Control Group: \*Inclusion Criteria: * No psychiatric diagnosis * No systemic or immunological illness * Medication-free for at least one month * Age ≥ 18 years and \<65 years * Provided informed consent For Healthy Control Group: \*Exclusion Criteria: • Hypertension * Diabetes mellitus * Chronic kidney disease * Rheumatoid arthritis * Systemic lupus erythematosus * Cardiac illness * Severe neurological disorders * Immunological or systemic illness * Primary psychiatric disorders other than schizophrenia * Alcohol/drug/substance use
Where this trial is running
Elâzığ, Elâzığ
- Elazığ Mental Health and Diseases Hospital — Elâzığ, Elâzığ, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist
- Email: mhorum@hotmail.com
- Phone: +905382207558
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.