ECG Findings in Methamphetamine Use

NCT07459244 | Recruiting DMC

• 1 other identifier: EMHDH-2025/26-METH-ECG-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Use Disorder; Methamphetamine Induced Psychosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Electrocardiogram (ECG)

  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.

  At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)

Secondary Outcomes (3)

• Complete Blood Count (CBC)

  At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)

• Positive and Negative Syndrome Scale (PANSS) Score

  At baseline and at 6 weeks of hospitalization

• Insight Assessment Scale (IAS)

  At baseline and at 6 weeks of hospitalization

Study Arms (3)

Methamphetamine Use Disorder (MUD)

Adult participants (18-65 years) diagnosed with Methamphetamine Use Disorder according to DSM-5-TR criteria. No intervention was/will be assigned by the study protocol. Participants were/will be evaluated at baseline and after 6 weeks of routine clinical treatment. Electrocardiogram (ECG) and complete blood count were/will be obtained from participants at baseline and after six weeks of follow-up. No psychometric scales were/will be administered to this group. Sociodemographic and clinical data were/will be recorded for all participants.

Methamphetamine-Induced Psychotic Disorder (MP)

Adult participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder according to DSM-5-TR criteria. No intervention was/will be assigned by the study protocol. Participants were/will be evaluated at baseline and after 6 weeks of routine clinical treatment. Electrocardiogram (ECG) and complete blood count were/will be obtained from participants at baseline and after six weeks of follow-up. Psychotic symptom severity was/will be assessed using the Positive and Negative Syndrome Scale (PANSS). Insight Assessment Scale (IAS) was/will be used to measure the insight level. Sociodemographic and clinical data were/will be recorded for all participants.

Healthy Control (HC)

Healthy control (HC) adult participants (18-65 years) without any current or past psychiatric disorder. No intervention was administered as part of the research protocol. Participants underwent a baseline clinical evaluation and provided a single blood sample for measurement of complete blood count. Sociodemographic and clinical data were recorded for all participants. As of December 15, 2025, the recruitment of HC participants has been completed.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted/will be consisted of adult male inpatients aged 18-65 years who were admitted to Elazığ Mental Health and Diseases Hospital. The methamphetamine-induced psychotic disorder (MP) group included/will include consecutive inpatients diagnosed with MP and the methamphetamine use disorder (MUD) group included/will include consecutive inpatients diagnosed with MUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Both patient groups consisted of active methamphetamine users and were hospitalized for clinical management at the time of assessment. Urine toxicology screening was performed at admission to confirm substance use status. The Healthy Control (HC) group consisted of adult male individuals without current or past psychiatric disorders and without substance use disorders, matched to patient groups in terms of age and body mass index. HCs had no significant medical illnesses.

You may qualify if:

• 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:

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Elazığ Mental Health and Diseases Hospital: lead

Study Sites (1)

Elazığ Mental Health and Diseases Hospital

Elâzığ, Elâzığ, 23200, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist

CONTACT

+905382207558; mhorum@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, Psychiatrist

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: April 7, 2025
• Primary Completion: April 6, 2026
• Study Completion: May 11, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal. Requests must be approved by the principal investigator and may require a data use agreement in accordance with institutional and ethical regulations.

Locations

TU (1)