ECG Findings in Methamphetamine Use

Official title

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

Overview

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.

Primary outcome measures

• Electrocardiogram (ECG) [Time frame: At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)]

Secondary outcome measures (3)

• Complete Blood Count (CBC) [Time frame: At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)]
• Positive and Negative Syndrome Scale (PANSS) Score [Time frame: At baseline and at 6 weeks of hospitalization]
• Insight Assessment Scale (IAS) [Time frame: At baseline and at 6 weeks of hospitalization]

Eligibility criteria

• 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
• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Elazığ Mental Health and Diseases Hospital — Elâzığ

Publications

• Demir B, Ozsoy F, Buyuk A, Altindag A. The effects of methamphetamine on electrocardiographic parameters in male patients. Int J Psychiatry Clin Pract. 2022 Nov;26(4):381-386. doi: 10.1080/13651501.2022.2041671. Epub 2022 Feb 28. PMID 35225724
• Schwarzbach V, Lenk K, Laufs U. Methamphetamine-related cardiovascular diseases. ESC Heart Fail. 2020 Apr;7(2):407-414. doi: 10.1002/ehf2.12572. Epub 2020 Jan 17. PMID 31950731
• Kevil CG, Goeders NE, Woolard MD, Bhuiyan MS, Dominic P, Kolluru GK, Arnold CL, Traylor JG, Orr AW. Methamphetamine Use and Cardiovascular Disease. Arterioscler Thromb Vasc Biol. 2019 Sep;39(9):1739-1746. doi: 10.1161/ATVBAHA.119.312461. Epub 2019 Aug 21. PMID 31433698
• Glasner-Edwards S, Mooney LJ. Methamphetamine psychosis: epidemiology and management. CNS Drugs. 2014 Dec;28(12):1115-26. doi: 10.1007/s40263-014-0209-8. PMID 25373627
• Courtney KE, Ray LA. Methamphetamine: an update on epidemiology, pharmacology, clinical phenomenology, and treatment literature. Drug Alcohol Depend. 2014 Oct 1;143:11-21. doi: 10.1016/j.drugalcdep.2014.08.003. Epub 2014 Aug 17. PMID 25176528

Identifiers

NCT: NCT07459244 · EMHDH-2025/26-METH-ECG-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗