Methamphetamine Induced PsychosisNCT07459270
Psychiatric Symptom Characteristics in Methamphetamine-Induced Psychosis With and Without Lifetime Cannabis Use
An observational study of Methamphetamine Induced Psychosis and Cannabis Use, run by Elazığ Mental Health and Diseases Hospital at 2 sites in Turkey (Türkiye).
Trial summary
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). 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, Cannabis Use
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Mar 2026to 23 Nov 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 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.
Who may be able to join
- Diagnosis of MP according to DSM-5-TR
- Diagnosis of Cannabis Use Disorder 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 plus Lifetime Cannabis Use (MP + LCU) Group:
Show all 11Show fewer
- 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 without LCU) Group:
Who cannot join
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
Show all 21Show fewer
- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than MP
- Alcohol use disorder
- For Methamphetamine-Induced Psychotic Disorder (MP without LCU) 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Elazığ Mental Health and Diseases Hospital
Elâzığ, Elâzığ, 23200
Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist, +905382207558, mhorum@hotmail.com
- Recruiting
Elazığ Mental Health and Diseases Hospital
Elâzığ, Elâzığ, 23200
Mehmet Hamdi ÖRÜM MHÖ Assoc. Prof., Assoc. Prof., +905382207558, mhorum@hotmail.com
About this study
Official title: Investigation of Factors Associated With Psychiatric Symptoms in Participants Diagnosed With Methamphetamine-Induced Psychotic Disorder With and Without Lifetime Cannabis Use
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.
Read the detailed description
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.
- Conditions
- Methamphetamine Induced Psychosis, Cannabis Use
- Keywords
- Methamphetamine, Cannabis, Marijuana, Psychiatric Symptoms, Longitudinal Study, Methamphetamine-Induced Psychotic Disorder, Lifetime Cannabis Use
- Medical subject headings
- Marijuana Abuse
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-Induced Psychotic Disorder + Lifetime Cannabis Use (MP + LCU) | 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. | |
| Methamphetamine-Induced Psychotic Disorder - Lifetime Cannabis Use (MP - LCU) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: It will be administered once a week for eight weeks.
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 start16 Mar 2026
- Primary completion14 Sep 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine Induced PsychosisStudies 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
- 90 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
- NCT07459270
- Sponsor's protocol ID
- EMHDH-2026-METH-CANNABIS-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 \[including sociodemographic variables, Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale, Pittsburgh Sleep Quality Index\] 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.
Publications
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 28282630Wearne 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 30364176Rogers JM, Iudicello JE, Marcondes MCG, Morgan EE, Cherner M, Ellis RJ, Letendre SL, Heaton RK, Grant I. The Combined Effects of Cannabis, Methamphetamine, and HIV on Neurocognition. Viruses. 2023 Mar 3;15(3):674. doi: 10.3390/v15030674.
PubMed 36992383Orum D, Orum MH, Kapici Y, Abus S. Ten-year cardiovascular disease risk and related factors in lifetime marijuana use with comorbid methamphetamine-associated psychotic disorder: a QRISK(R)3 study. BMC Psychiatry. 2024 Aug 19;24(1):563. doi: 10.1186/s12888-024-06018-1.
PubMed 39160490Glasner-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 25176528Schulenberg JE, Merline AC, Johnston LD, O'Malley PM, Bachman JG, Laetz VB. Trajectories of Marijuana Use During the Transition to Adulthood: The Big Picture Based on National Panel Data. J Drug Issues. 2005;35(2):255-279. doi: 10.1177/002204260503500203.
PubMed 16534532
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Associated With Psychiatric Symptoms in Participants Diagnosed With Methamphetamine-Induced Psychotic Disorder With and Without Lifetime Cannabis Use
- ClinicalTrials.gov ID
- NCT07459270
- Acronym / sponsor ID
- EMHDH-2026-METH-CANNABIS-01
- Conditions
- Methamphetamine Induced Psychosis, Cannabis Use
- Keywords
- Methamphetamine, Cannabis, Marijuana, Psychiatric Symptoms, Longitudinal Study, Methamphetamine-Induced Psychotic Disorder, Lifetime Cannabis Use
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Elazığ Mental Health and Diseases HospitalOther government
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 14 Sep 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methamphetamine-Induced Psychotic Disorder + Lifetime Cannabis Use (MP + LCU) | – | –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. |
| Methamphetamine-Induced Psychotic Disorder - Lifetime Cannabis Use (MP - LCU) | – | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- For Methamphetamine-Induced Psychotic Disorder plus Lifetime Cannabis Use (MP + LCU) Group:
Key exclusion criteria (21 listed)
- For Methamphetamine-Induced Psychotic Disorder (MP without LCU) Group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Insight Assessment Scale (IAS)
Time frame: It will be administered once a week for eight weeks.
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.
Addiction Profile Index Clinical-Practitioner Form (API-C)
Time frame: It will be administered once a week for eight weeks.
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.
Positive and Negative Syndrome Scale (PANSS)
Time frame: It will be administered once a week for eight weeks.
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.
Global Assessment Scale (GAS)
Time frame: It will be administered once a week for eight weeks.
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: It will be administered once a week for eight weeks.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 28282630McKetin 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.
- Background: PubMed 30364176Wearne 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.
- Background: PubMed 36992383Rogers JM, Iudicello JE, Marcondes MCG, Morgan EE, Cherner M, Ellis RJ, Letendre SL, Heaton RK, Grant I. The Combined Effects of Cannabis, Methamphetamine, and HIV on Neurocognition. Viruses. 2023 Mar 3;15(3):674. doi: 10.3390/v15030674.
- Background: PubMed 39160490Orum D, Orum MH, Kapici Y, Abus S. Ten-year cardiovascular disease risk and related factors in lifetime marijuana use with comorbid methamphetamine-associated psychotic disorder: a QRISK(R)3 study. BMC Psychiatry. 2024 Aug 19;24(1):563. doi: 10.1186/s12888-024-06018-1.
- Background: PubMed 25373627Glasner-Edwards S, Mooney LJ. Methamphetamine psychosis: epidemiology and management. CNS Drugs. 2014 Dec;28(12):1115-26. doi: 10.1007/s40263-014-0209-8.
- Background: PubMed 25176528Courtney 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.
- Background: PubMed 16534532Schulenberg JE, Merline AC, Johnston LD, O'Malley PM, Bachman JG, Laetz VB. Trajectories of Marijuana Use During the Transition to Adulthood: The Big Picture Based on National Panel Data. J Drug Issues. 2005;35(2):255-279. doi: 10.1177/002204260503500203.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methamphetamine Induced Psychosis and Cannabis Use, run by Elazığ Mental Health and Diseases Hospital at 2 sites 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 11 inclusion and 21 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 2 sites 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?
Insight Assessment Scale (IAS) (time frame: It will be administered once a week for eight weeks.). The study lists 5 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 NCT07459270, which also lists 7 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.