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NCT Number: NCT07459270

Psychiatric Symptom Characteristics in Methamphetamine-Induced Psychosis 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Elazığ Mental Health and Diseases Hospital

Elâzığ, 23200, Turkey (Türkiye)

Location contact

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

CONTACT

[email protected]

+905382207558

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+905382207558

Sponsors and collaborators

Lead sponsor

Elazığ Mental Health and Diseases Hospital

Other Gov

Registry information

Official study title

Investigation of Factors Associated With Psychiatric Symptoms in Participants Diagnosed With Methamphetamine-Induced Psychotic Disorder With and Without Lifetime Cannabis Use

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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