Methamphetamine Use DisorderNCT07459244
ECG Findings in Methamphetamine Use
An observational study of Methamphetamine Use Disorder and Methamphetamine Induced Psychosis, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Use Disorder, Methamphetamine Induced Psychosis
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2025to 22 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
- Diagnosis of MP according to DSM-5-TR
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- 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:
- 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:
Who cannot join
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
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- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than MUD
- Alcohol use disorder
- For Methamphetamine-Induced Psychotic Disorder (MP) Group:
- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Elazığ Mental Health and Diseases Hospital
Elâzığ, Elâzığ, 23200
Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist, +905382207558, mhorum@hotmail.com
About this study
Official title: Electrocardiogram Findings in Methamphetamine Use Disorder and Methamphetamine-Induced Psychotic Disorder: A Prospective Observational Cohort Study
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.
Read the 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.
- Keywords
- Methamphetamine, Methamphetamine Use Disorder, Methamphetamine-Induced Psychosis, Electrocardiography, Cardiac Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)
Secondary outcomes (3)
Complete Blood Count (CBC)
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.
Measured: At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)
Positive and Negative Syndrome Scale (PANSS) Score
Positive 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.
Measured: At baseline and at 6 weeks of hospitalization
Insight Assessment Scale (IAS)
It 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.
Measured: At baseline and at 6 weeks of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start7 Apr 2025
- Primary completion2 Nov 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elazığ Mental Health and Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Hamdi ÖRÜM, Elazığ Mental Health and Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459244
- Sponsor's protocol ID
- EMHDH-2025/26-METH-ECG-01
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the results reported in this study \[including demographic variables, electrocardiogram (ECG), complete blood count parameters, and Positive and Negative Syndrome Scale (PANSS) and Insight Assessment Scale (IAS)\] will be made available to qualified researchers upon reasonable request for academic purposes. Data will be shared after removal of all direct identifiers and in accordance with applicable ethical approvals and data protection regulations. Access to the data will require a methodologically sound research proposal and a data use agreement. Requests should be directed to the corresponding author.
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.
PubMed 35225724Schwarzbach 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.
PubMed 31950731Kevil 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.
PubMed 31433698Glasner-Edwards S, Mooney LJ. Methamphetamine psychosis: epidemiology and management. CNS Drugs. 2014 Dec;28(12):1115-26. doi: 10.1007/s40263-014-0209-8.
PubMed 25373627Courtney 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.
PubMed 25176528