Psychiatric Symptom Characteristics in Methamphetamine-Induced Psychosis With and Without Lifetime Cannabis Use

NCT07459270 | Not Yet Recruiting DMC

• 1 other identifier: EMHDH-2026-METH-CANNABIS-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Cannabis Use; Methamphetamine Induced Psychosis

Keywords

Methamphetamine; Cannabis; Marijuana; Psychiatric Symptoms; Longitudinal Study; Methamphetamine-Induced Psychotic Disorder; Lifetime Cannabis Use

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  It will be administered once a week for eight weeks.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Elazığ Mental Health and Diseases Hospital: lead

Study Sites (1)

Elazığ Mental Health and Diseases Hospital

Elâzığ, Elâzığ, 23200, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 28282630 BACKGROUND

• Wearne TA,Cornish JL

  BACKGROUND

• 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.

  PMID: 36992383 BACKGROUND

• 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.

  PMID: 39160490 BACKGROUND

• 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.

  PMID: 25373627 BACKGROUND

• Courtney KE,Ray LA

  BACKGROUND

• Schulenberg JE,Merline AC,Johnston LD,O'Malley PM,Bachman JG,Laetz VB

  BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

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

CONTACT

+905382207558; mhorum@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, Psychiatrist

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

TU (1)