Substance Misuse To Psychosis for Ketamine (SToP-K)

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.

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Key information

Conditions

Ketamine Abuse Chemically-Induced Disorders Disease Attributes Disease Susceptibility Genetic Predisposition Genetic Predisposition to Disease Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Substance Use Disorders Substance-Related Disorders

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital, Hong Kong

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

genome testing

Diagnostic Test

blood sampling via venipuncture

Primary outcomes

relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis

Time frame: During the 2 year study period

relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis

Secondary outcomes

Gene association to development of psychcosis

Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Substance Misuse To Psychosis for Ketamine (SToP-K) -Who is At Risk? A Case-Control Study in Ketamine and Non-Ketamine-Using Substance Abusers

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Apr 2, 2018
Registry last updated: Jul 31, 2020

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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