ECG changes in adults using methamphetamine with and without psychosis
Electrocardiogram Findings in Methamphetamine Use Disorder and Methamphetamine-Induced Psychotic Disorder: A Prospective Observational Cohort Study
This project will see if heart ECG measurements differ between adults hospitalized for methamphetamine use who have psychosis and those who do not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | Elazığ Mental Health and Diseases Hospital Government |
| Locations | 1 site (Elâzığ, Elâzığ) |
| Trial ID | NCT07459244 on ClinicalTrials.gov |
What this trial studies
This is a prospective cohort study conducted on the closed inpatient psychiatric ward at Elazığ Mental Health and Diseases Hospital enrolling adults with DSM-5-TR diagnoses of Methamphetamine Use Disorder or Methamphetamine-Induced Psychotic Disorder and positive urine methamphetamine. Standard 12-lead ECGs will be recorded at hospital admission and again during remission prior to discharge, and parameters such as QTc, QT dispersion, Tp-e interval, Tp-e/QTc ratio, ST changes, and P-wave dispersion will be measured. Groups will be compared to determine whether methamphetamine-induced psychosis is associated with greater ECG abnormalities and inferred cardiac risk compared with methamphetamine use without psychosis. Subjects with major medical comorbidities (e.g., hypertension, diabetes, known cardiac disease) or primary psychiatric disorders other than the specified diagnoses are excluded to reduce confounding.
Who should consider this trial
Good fit: Adults aged 18–64 hospitalized at Elazığ Mental Health and Diseases Hospital with confirmed methamphetamine use (positive urine toxicology), medication-free for at least one month, and diagnosed with either Methamphetamine Use Disorder or Methamphetamine-Induced Psychotic Disorder by DSM-5-TR criteria are eligible.
Not a fit: People with pre-existing cardiovascular disease, hypertension, diabetes, significant systemic illness, primary psychiatric disorders other than MUD or MP, alcohol use disorder, or those not treated at the study hospital are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify patients with methamphetamine-induced psychosis who are at higher short-term cardiac risk so they can receive closer monitoring or early interventions.
How similar studies have performed: Previous studies have reported ECG abnormalities in methamphetamine users, but prospective electrocardiographic study specifically in methamphetamine-induced psychosis is novel.
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.