An observational study in Methamphetamine Induced Psychosis and Cannabis Use, sponsored by Elazığ Mental Health and Diseases Hospital. Recruiting at 2 sites in Turkey (Türkiye). Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Elazığ Mental Health and Diseases Hospital · Observational
This prospective cohort study aims to investigate factors associated with psychiatric symptom severity in participants diagnosed with methamphetamine-induced psychotic disorder (MP) with and without lifetime cannabis use (LCU). Participants hospitalized at Elazığ Mental Health and Diseases Hospital who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MP will be included.
Participants will be divided into two groups based on the presence or absence of LCU. Psychiatric symptoms and clinical characteristics will be assessed weekly during an eight-week inpatient follow-up period using standardized psychometric instruments.
The study aims to determine whether LCU influences the course and severity of psychiatric symptoms in MP and to identify environmental, individual, and familial factors associated with symptom progression.
Methamphetamine is a synthetic central nervous system stimulant with strong addictive potential and significant neurotoxic effects. Chronic methamphetamine exposure causes dopaminergic dysregulation and may lead to the development of psychotic symptoms, including hallucinations, delusions, and behavioral disturbances. Methamphetamine-induced psychotic disorder (MP) occurs in a substantial proportion of individuals who use methamphetamine.
Cannabis use is frequently observed among individuals who use methamphetamine. Lifetime cannabis use (LCU) has been associated with a variety of psychiatric symptoms including anxiety, irritability, sleep disturbances, cognitive impairment, and psychotic symptoms. However, the effect of LCU on the course of MP has not been clearly established.
Most existing studies examining psychotic symptoms in MP have been cross-sectional or retrospective in design. Prospective cohort studies investigating symptom progression and associated risk factors remain limited.
This study is designed as a prospective cohort study and will conduct in participants hospitalized at Elazığ Mental Health and Diseases Hospital psychiatry inpatient clinic. Participants diagnosed with MP according to (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) DSM-5-TR criteria will be included and divided into two groups: Group 1=Participants with MP plus LCU (MP+LCU), Group 2=Participants with MP (no current and lifetime cannabis use).
LCU will be defined as using cannabis three or more times within the past 30 days and/or using cannabis more than forty times during the past year.
Participants will be followed weekly for eight weeks during hospitalization. Psychiatric symptoms, substance/drug use characteristics, and psychosocial variables will be assessed using standardized psychometric instruments.
The scales used/will be used in this study are as follows: Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale, Pittsburgh Sleep Quality Index.
The primary aim of this study is to identify environmental, familial, and individual factors associated with psychiatric symptom severity in participants with MP and to determine whether LCU affects symptom progression.
After completion of the follow-up period, the data will be analyzed using a statistical software and the results will be prepared for publication in scientific journals.
Elazığ Mental Health and Diseases Hospital is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult male participants aged 18-65 years who were admitted to Elazığ Mental Health and Diseases Hospital.
The methamphetamine-induced psychotic disorder (MP) with and without lifetime cannabis use (LCU) group will include consecutive participants diagnosed with MP with and without LCU according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR).
Both groups will consist of active methamphetamine users and will be hospitalized for clinical management at the time of assessment. Urine toxicology screening was performed at admission to confirm substance/drug use status.
For Methamphetamine-Induced Psychotic Disorder plus Lifetime Cannabis Use (MP + LCU) Group:
*Inclusion Criteria:
For Methamphetamine-Induced Psychotic Disorder plus Lifetime Cannabis Use (MP + LCU) Group:
*Exclusion Criteria:
For Methamphetamine-Induced Psychotic Disorder (MP without LCU) Group:
*Inclusion Criteria:
For Methamphetamine-Induced Psychotic Disorder (MP without LCU) Group:
*Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult male participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder plus Lifetime Cannabis Use (MP + LCU) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. No intervention was/will be assigned by the study protocol. At baseline, participants will complete a sociodemographic and clinical information form. Psychiatric symptoms and addiction-related characteristics will be assessed using standardized psychometric scales. Participants will then be followed prospectively for eight weeks. The scales will be used in this study are as follows: Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale, Pittsburgh Sleep Quality Index.
Adult male participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder (no lifetime cannabis use) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. No intervention was/will be assigned by the study protocol. At baseline, participants will complete a sociodemographic and clinical information form. Psychiatric symptoms and addiction-related characteristics will be assessed using standardized psychometric scales. Participants will then be followed prospectively for eight weeks. The scales will be used in this study are as follows: Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale, Pittsburgh Sleep Quality Index.
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.
Time frame: It will be administered once a week for eight weeks.
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.
Time frame: It will be administered once a week for eight weeks.
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.
Time frame: It will be administered once a week for eight weeks.
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.
Time frame: It will be administered once a week for eight weeks.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI, which assesses sleep quality over the past month, consists of 24 questions. Nineteen of these are self-report questions answered by the patient, while five questions are answered by a spouse or roommate and are used for clinical information only and are not included in the score. The last self-report question (question 19) concerns the presence of a roommate or spouse and is not used in the scoring. The total score ranges from 0 to 21. A total score higher than 5 indicates poor sleep quality.
Time frame: It will be administered once a week for eight weeks.
Plan to share: Yes — Deidentified individual participant data (IPD) underlying the results reported in this study [including sociodemographic variables, Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale, Pittsburgh Sleep Quality Index] 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.
Supporting information: 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.
Started Mar 2026 (actual). Primary completion is estimated for Sep 2026, 5 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Elazığ Mental Health and Diseases Hospital