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ECG Findings in Methamphetamine Use

Electrocardiogram Findings in Methamphetamine Use Disorder and Methamphetamine-Induced Psychotic Disorder: A Prospective Observational Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07459244
Enrollment
240
Registered
2026-03-09
Start date
2025-04-07
Completion date
2026-12-22
Last updated
2026-09-10

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

Conditions

Methamphetamine Induced Psychosis, Methamphetamine Use Disorder

Keywords

Methamphetamine, Methamphetamine Use Disorder, Methamphetamine-Induced Psychosis, Electrocardiography, Cardiac Risk

Brief summary

This prospective cohort study aims to examine and compare electrocardiogram (ECG) parameters in subjects diagnosed with Methamphetamine Use Disorder (MUD) and Methamphetamine-Induced Psychotic Disorder (MP) during inpatient psychiatric treatment. ECG findings at hospital admission and during remission prior to discharge will be evaluated and compared between groups. The study also aims to determine whether methamphetamine-induced psychosis is associated with greater ECG abnormalities and increased cardiac risk compared to methamphetamine use without psychosis.

Detailed description

Methamphetamine is a potent central nervous system stimulant associated with addiction, neurotoxicity, and increased cardiovascular morbidity and mortality. Chronic methamphetamine exposure leads to sympathetic nervous system activation, elevated catecholamine levels, hypertension, myocardial ischemia, arrhythmias, cardiomyopathy, and increased risk of sudden cardiac death. Cardiovascular complications in methamphetamine users may result from repeated catecholamine surges, endothelial damage, coronary vasospasm, thrombus formation, myocardial fibrosis, and electrical instability. Electrocardiogram (ECG) abnormalities such as prolonged QTc interval, QT dispersion (QTd), Tp-e interval prolongation, Tp-e/QTc ratio increase, ST depression, and P-wave dispersion may reflect arrhythmogenic risk. Previous studies have demonstrated ECG abnormalities in subjects with Methamphetamine Use Disorder (MUD). However, electrocardiographic findings in Methamphetamine-Induced Psychotic Disorder (MP) have not been prospectively investigated. Evidence suggests that subjects with MP may have higher long-term cardiovascular risk compared to subjects with MUD. This study is designed as a prospective cohort study conducted in the closed inpatient psychiatric ward of Elazığ Mental Health and Diseases Hospital. Subjects hospitalized with a diagnosis of MUD or MP according to DSM-5-TR criteria will be included. Only subjects with positive urine toxicology for methamphetamine at admission will be enrolled. At hospital admission and prior to discharge (remission period), the following routine clinical data will be recorded: ECG, Complete blood count. ECG parameters to be evaluated include: QT interval, QTc interval, QRS duration, Tp-e interval, Tp-e/QTc ratio, ST depression, P-wave dispersion, QT dispersion, fragmented QRS. ECGs will be interpreted by a cardiology specialist, and pathological findings will be documented. Psychiatric symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS). Sociodemographic and substance use characteristics will also be recorded. Admission ECG findings will be compared with remission ECG findings within groups, and ECG parameters will be compared between MUD and MP groups to determine whether psychosis is associated with increased cardiac risk. Statistical analyses will be performed using SPSS version 26. Appropriate parametric or non-parametric tests will be used depending on data distribution. Independent and dependent sample analyses will be conducted. Correlation, regression, and ROC analyses will be performed where appropriate. Statistical significance will be defined as p\<0.05. When the alpha value is accepted as 0.05, the beta value as 0.2 and the power as 80%, it was concluded that there should be at least 3 participants in each group. In this study, we plan to form each group with 80 participants.

Interventions

None listed

Sponsors

Elazığ Mental Health and Diseases Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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: \*

Design outcomes

Primary

MeasureTime frameDescription
Electrocardiogram (ECG)At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)The process of recording these electrical currents generated in the heart on paper is called an electrocardiogram (ECG). An ECG consists of waves. These waves are composed of P, Q, R, S, T waves and various intervals (such as the PR interval and QT interval). The P wave occurs during the contraction of the atria, and the QRS wave occurs during the contraction of the ventricles. ECG parameters to be evaluated include: QT interval, QTc interval, QRS duration, Tp-e interval, Tp-e/QTc ratio, ST depression, P-wave dispersion, QT dispersion, fragmented QRS.

Secondary

MeasureTime frameDescription
Complete Blood Count (CBC)At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)A complete blood count (CBC) is a group of blood tests that measure the number and size of the different cells in blood. A CBC measures red blood cells, white blood cells, platelets, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, mean corpuscular hemoglobin, lymphocyte, neutrophil, monocyte, eosinophil, basophil, red blood cell distribution width.
Positive and Negative Syndrome Scale (PANSS) ScoreAt baseline and at 6 weeks of hospitalizationPositive and Negative Syndrome Scale (PANSS) was developed to assess positive and negative symptoms and general psychopathology in patients with schizophrenia-spectrum disorder, and to measure the level of these symptoms. It is administered via a semi-structured interview, taking into account the last week. Information can also be obtained from the patient's relatives and healthcare staff. It consists of a total of 30 items: 7 items addressing positive symptoms, 7 addressing negative symptoms, and 16 addressing general psychopathology symptoms. Each item is scored from 1 to 7, and the scores are summed for the final score. This scale was only administered to the methamphetamine-induced psychotic disorder group.
Insight Assessment Scale (IAS)At baseline and at 6 weeks of hospitalizationIt was reported that insight cannot be evaluated as either present or absent, and it was defined it as a three-way process consisting of compliance with treatment, awareness of the illness, and accurate recognition of psychotic experiences. Based on these components, Insight Assessment Scale (IAS) was developed as a clinician-administered scale that quantitatively assesses insight for individuals with psychosis. IAS is an 8-question, clinician-administered, semi-structured scale. "Treatment acceptance"(1a), " treatmentrequest" (1b), "knowledge of illness" (2a), "knowledge of mental illness" (2b), "explanation of illness" (2c), "In addition to the 7 subscales titled "believing in the truth of the delusion" (3a), "explaining their experiences" (3b), there is a subscale titled "reaction to disbelief". The highest total score with this question is 18. A high score indicates a high level of insight. This scale was only administered to the methamphetamine-induced psychotic disorder group.

Countries

Turkey (Türkiye)

Contacts

CONTACTMehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist
mhorum@hotmail.com+905382207558

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026