Substance Misuse To Psychosis for Ketamine (SToP-K)

Completed

• Conditions: Genetic Predisposition; Substance Use Disorders; Ketamine Abuse; Psychotic Disorders; Schizophrenia
• Interventions: Diagnostic Test: genome testing

• Registration Number: NCT03485339
• Lead Sponsor: The University of Hong Kong

Brief Summary

Evidence suggests that repeated or chronic ketamine use, as compared to acute ketamine users, posed a higher clinical risk of developing psychotic disorders, potentially related to the underlying chronic N-methyl-D-aspartate receptor (NMDAR) dysfunction, and a higher risk of suffering from schizophrenia particularly in those genetically susceptible, or genetically predisposed ketamine abusers. With ketamine infusion rises as a emerging hope as an acute treatment for depression and suicidality under the shadow of unknown longer term psychotomimetic effects peculiarly amongst repeated or chronic use, the current case-control study aims to investigate: a) if repeated or chronic ketamine use is associated with an increased risk of psychosis by comparing those ketamine abusers with and without psychosis, and to those non-ketamine-using drug abusers with psychosis; and b) if genetic predisposition from single nucleotide polymorphisms are associated with risk of psychosis in ketamine abusers.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-25
• Study First Posted: 2018-04-02
• Study Start: 2018-06-12
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Age: 12 - 65 years old
• Able to read and communicate in English and/or Chinese
• Able to give informed consent
• Self-reported to have psychoactive substance use continuously for ≥3 month
• At least one positive urine toxicology result showing the reported psychoactive substance being used

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Exclusion Criteria

• Age <12 years old
• Unable to read English or Chinese
• Unable to give informed consent
• Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10, F70-73)
• Had been diagnosed to have primary psychosis prior to the use of any psychoactive substances, including alcohol
• Had been diagnosed to have "bipolar and related disorder" prior to the use of any psychoactive substances, including alcohol
• Had been diagnosed to have "major depressive disorder with psychotic features" prior to the use of any psychoactive substances, including alcohol
• Had been diagnosed to have "psychotic disorder due to another medical condition" (DMS-5)
• Self-reported to have abstained from any psychoactive substance use continuously for ≥12 months AND with negative urine toxicology result at the time of recruitment/ intake at the psychiatric services as recorded on case notes

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	genome testing	Ketamine user with psychotic disorders
Control Group 1	genome testing	Ketamine user without psychotic disorders
Control Group 2	genome testing	Non-ketamine-using drug user with psychotic disorders

Primary Outcome Measures

Name	Time	Method
relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis	During the 2 year study period	relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis

Secondary Outcome Measures

Name	Time	Method
Gene association to development of psychcosis	During the 2 year study period	The single nucleotide polymorphism of 4 genes associated with N-methyl-D-aspartate and dopamine receptors being associated with the development of psychosis in ketamine abuser

Trial Locations

Locations (2)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Western Psychiatric Centre; 🇭🇰 Hong Kong, Hong Kong