Substance Misuse To Psychosis for Ketamine (SToP-K)

Schizophrenia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485339
• Other study ID #: SToP-K_CC
• Status: Completed
• Start date: June 12, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Ketamine Abuse
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Diagnostic Test:
• genome testing
blood sampling via venipuncture

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Western Psychiatric Centre	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis	relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis	During the 2 year study period
Secondary	Gene association to development of psychcosis	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	During the 2 year study period