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Methamphetamine Induced PsychosisNCT07459257

Psychiatric Symptom Predictors in Methamphetamine-Induced Psychosis

An observational study of Methamphetamine Induced Psychosis, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This longitudinal observational study aimed to investigate environmental, familial, and individual factors associated with psychiatric symptom severity in participants diagnosed with methamphetamine-induced psychotic disorder (MP). 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 Induced Psychosis
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Feb 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 participants 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 participants diagnosed with MP according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). MP group consisted/will 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/drug use status.

Who may be able to join

  • 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
  • Methamphetamine-Induced Psychotic Disorder (MP) Group:

Who cannot join

  • Hypertension
  • Diabetes mellitus
  • Chronic kidney disease
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Cardiac illness
Show all 10Show fewer
  • Severe neurological disorders
  • Immunological or systemic illness
  • Primary psychiatric disorders other than MP
  • Alcohol use disorder

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

+905382207558

mhorum@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Elazığ Mental Health and Diseases Hospital

    Elâzığ, Elâzığ, 23200

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

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Factors Associated With Psychiatric Symptoms in Methamphetamine-Induced Psychotic Disorder: One-Year Longitudinal Study

This longitudinal observational study aimed to investigate environmental, familial, and individual factors associated with psychiatric symptom severity in participants diagnosed with methamphetamine-induced psychotic disorder (MP). Participants diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR) criteria was followed/will be followed prospectively for one year. Sociodemographic characteristics, treatment adherence, perceived social support, addiction-related clinical variables, insight levels, and psychotic symptoms was assessed/will be assessed monthly using standardized psychometric instruments.

The study aimed to identify predictors associated with relapse-remission patterns and changes in psychiatric symptoms over a one-year follow-up period.

Read the detailed description

Methamphetamine is a potent central nervous system stimulant associated with strong addictive potential and widespread global misuse. Chronic exposure to methamphetamine leads to neurotoxic effects, dopaminergic dysregulation, and increased risk of psychosis.

Methamphetamine-induced psychotic disorder (MP) presents with symptoms such as auditory and visual hallucinations, persecutory delusions, suspiciousness, and, in some participants, negative symptoms including social withdrawal and reduced self-care. Although Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR) indicates that substance/drug-induced psychosis may resolve within one month, clinical observations suggest that psychotic symptoms may persist longer in some individuals.

Most previous studies investigating MP have used cross-sectional or retrospective designs. Longitudinal data describing the progression of psychiatric symptoms, relapse patterns, and factors influencing clinical outcomes remain limited.

The primary aim of the study was to identify environmental, familial, and individual factors influencing psychiatric symptom severity over time. Variables of interest include substance/drug use patterns, medication adherence, social support, insight levels, and addiction-related clinical features.

This study was designed as a one-year longitudinal follow-up study conducted at Elazığ Mental Health and Diseases Hospital. Male individuals diagnosed with MP according to DSM-5-TR criteria was enrolled/will be enrolled.

A sociodemographic and clinical information form was/will be administered to participants upon their initial admission. Psychiatric symptoms and addiction-related characteristics were/will be assessed using standardized psychometric scales. Participants were followed/will be followed prospectively for twelve months. Participants' contact information was/will be obtained (permission to contact them by phone was/will also be obtained), and the same psychometric scales and substance/drug use characteristics was/will be collected regularly once a month. A total of 12 interviews was/will be conducted with the same participant within 12 months. In each interview, particular attention was/will be paid to where they have lived in the last month and whether there have been any changes in their sociodemographic information. At the end of the monthly periods, participants who have not admitted to the hospital was/will be contacted by phone, and the fact that the interview was conducted by phone was/will be recorded (due to the possibility that the participants may have migrated to other cities or been imprisoned). Participants who cannot be reached despite all efforts (they was/will be called once a day for a week, and permission was/will be obtained for this) was/will have a note added to their "relevant month's" interview record indicating that the interview could not be conducted. At the end of each month, attempts was/will be made to contact all included participants again - regardless of whether they were reached the previous month or not - and the same procedures will continue each month. This means that even if a participant was only contacted upon admission and could not be contacted again, that participant was/will be included in the study. The aim here is to provide feedback on treatment and follow-up compliance in MP. The last participant was/will be included exactly one year after the start of the study, and 12 interviews was/will be conducted with this last participant over the course of a year. Participants included in the study with a diagnosis of MP during this one-year period will constitute the study sample.

The scales used/will be used in this study are as follows: Morisky Medication Adherence Scale, Multidimensional Scale of Perceived Social Support, Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale.

After completion of the follow-up period, the data will be analyzed using SPSS statistical software and the results will be prepared for publication in scientific journals.

Keywords
Methamphetamine, Methamphetamine-Induced Psychosis, Psychiatric Symptoms, Methamphetamine-Induced Psychotic Disorder, Longitudinal Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07459257
Study groupRoleWhat they receive
Methamphetamine-Induced Psychotic Disorder (MP)Adult male participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR) criteria. No intervention was/will be assigned by the study protocol. At baseline, participants completed/will complete a sociodemographic and clinical information form. Psychiatric symptoms and addiction-related characteristics will be assessed using standardized psychometric scales. Participants were followed/will then be followed prospectively for twelve months. Participants will be contacted monthly to complete the same clinical assessments. The scales used/will be used in this study are as follows: Morisky Medication Adherence Scale, Multidimensional Scale of Perceived Social Support, Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morisky Medication Adherence Scale (MMAS)

    The scale consists of four two-option (yes/no) closed-ended questions. In Turkey, a validity and reliability study was conducted to measure adherence to antipsychotic treatment. A "yes" answer indicates poor adherence to medical treatment. A "no" answer indicates good adherence to medical treatment. A higher number of "yes" answers indicates poor adherence to medical treatment.

    Measured: To be obtained/will be obtained once a month for 12 months.

  2. Multidimensional Scale of Perceived Social Support (MSPSS)

    The scale consists of 12 items. It is a 7-point Likert-type scale ranging from "Absolutely not 1, 2, 3, 4, 5, 6, 7 Absolutely yes". A higher score indicates higher perceived social support.

    Measured: To be obtained/will be obtained once a month for 12 months.

  3. 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: To be obtained/will be obtained once a month for 12 months.

  4. Addiction Profile Index Clinical-Practitioner Form (API-C)

    API was developed to measure the factors related to addiction. It is a measure of 37 questions and 5 subscales. Subscales measure the substance use characteristics, dependency diagnostic criteria, the effect of substance use on the individual's life, the craving for substance use and the motivation to quit substance use. API-C includes the assessment of the six areas related to the addiction apart from areas where the API measures directly. Two of these six areas measure mental status, while others measure some personal characteristics of addiction. These areas are; depression, anxiety, anger control failure, lack of safe behavior, excitement seeking behavior and impulsiveness. In addition to the 37 questions in the API, there are 21 more questions in the API-C. Self-notification and enforcement forms are available. In our study, API-C Practitioner Form was used.

    Measured: To be obtained/will be obtained once a month for 12 months.

  5. Positive and Negative Syndrome Scale (PANSS)

    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: To be obtained/will be obtained once a month for 12 months.

  6. Global Assessment Scale (GAS)

    It is a rating scale that is administered quickly and covers all aspects of changes in psychopathology (psychological, social, and occupational functioning). Developed in 1976, it is scored from 0 to 100. A lower score is associated with a lower level of functioning.

    Measured: To be obtained/will be obtained once a month for 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start3 Feb 2025
  3. Primary completion28 Jul 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459257
Sponsor's protocol ID
EMHDH-2025/26-METH-PSYCHS-LONG
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 \[including sociodemographic variables, Morisky Medication Adherence Scale, Multidimensional Scale of Perceived Social Support, Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale\] 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

  • Ghaffari-Nejad A, Ziaadini H, Saffari-Zadeha S, Kheradmand A, Pouya F. A study of the phenomenology of psychosis induced by methamphetamine: a preliminary research. Addict Health. 2014 Summer-Autumn;6(3-4):105-11.

    PubMed 25984277
  • McKetin R, Baker AL, Dawe S, Voce A, Lubman DI. Differences in the symptom profile of methamphetamine-related psychosis and primary psychotic disorders. Psychiatry Res. 2017 May;251:349-354. doi: 10.1016/j.psychres.2017.02.028. Epub 2017 Feb 13.

    PubMed 28282630
  • Wearne TA, Cornish JL. A Comparison of Methamphetamine-Induced Psychosis and Schizophrenia: A Review of Positive, Negative, and Cognitive Symptomatology. Front Psychiatry. 2018 Oct 10;9:491. doi: 10.3389/fpsyt.2018.00491. eCollection 2018.

    PubMed 30364176
  • 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.

    PubMed 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.

    PubMed 25176528

Questions about this trial

What is this clinical trial studying?

An observational study of Methamphetamine Induced Psychosis, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist (+905382207558, mhorum@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morisky Medication Adherence Scale (MMAS) (time frame: To be obtained/will be obtained once a month for 12 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07459257, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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