- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07459270
Psychiatric Symptom Characteristics in Methamphetamine-Induced Psychosis With and Without Lifetime Cannabis Use
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist
- Phone Number: +905382207558
- Email: mhorum@hotmail.com
Study Locations
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Elâzığ
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Elâzığ, Elâzığ, Turkey (Türkiye), 23200
- Elazığ Mental Health and Diseases Hospital
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Contact:
- Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist
- Phone Number: +905382207558
- Email: mhorum@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
For Methamphetamine-Induced Psychotic Disorder plus Lifetime Cannabis Use (MP + LCU) Group:
*Inclusion Criteria:
• 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:
*Exclusion Criteria:
• 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 Methamphetamine-Induced Psychotic Disorder (MP without LCU) Group:
*Inclusion Criteria:
• 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:
*Exclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Insight Assessment Scale (IAS)
Time Frame: It will be administered once a week for eight weeks.
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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.
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It will be administered once a week for eight weeks.
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Addiction Profile Index Clinical-Practitioner Form (API-C)
Time Frame: It will be administered once a week for eight weeks.
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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.
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It will be administered once a week for eight weeks.
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Positive and Negative Syndrome Scale (PANSS)
Time Frame: It will be administered once a week for eight weeks.
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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.
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It will be administered once a week for eight weeks.
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Global Assessment Scale (GAS)
Time Frame: It will be administered once a week for eight weeks.
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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.
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It will be administered once a week for eight weeks.
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: It will be administered once a week for eight weeks.
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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.
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It will be administered once a week for eight weeks.
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Collaborators and Investigators
Publications and helpful links
General 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.
- Wearne TA,Cornish JL
- Rogers 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.
- Orum 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.
- 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.
- Courtney KE,Ray LA
- Schulenberg JE,Merline AC,Johnston LD,O'Malley PM,Bachman JG,Laetz VB
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMHDH-2026-METH-CANNABIS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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