Trials / Recruiting
RecruitingNCT07459244
ECG Findings in Methamphetamine Use
Electrocardiogram Findings in Methamphetamine Use Disorder and Methamphetamine-Induced Psychotic Disorder: A Prospective Observational Cohort Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 240 (estimated)
- Sponsor
- Elazığ Mental Health and Diseases Hospital · Other Government
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2025-04-07
- Primary completion
- 2026-04-06
- Completion
- 2026-05-11
- First posted
- 2026-03-09
- Last updated
- 2026-03-09
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07459244. Inclusion in this directory is not an endorsement.