Substance Misuse To Psychosis for Ketamine (SToP-K)

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

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia; Substance Use Disorders; Genetic Predisposition; Ketamine Abuse
• Intervention / Treatment: Diagnostic test: genome testing

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Queen Mary Hospital
  • Hong Kong, Hong Kong, 00000
    • Western Psychiatric Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ketamine abuser and non-ketamine-using drug abusers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Ketamine user with psychotic disorders	Diagnostic test: genome testing; blood sampling via venipuncture
Control Group 1; Ketamine user without psychotic disorders	Diagnostic test: genome testing; blood sampling via venipuncture
Control Group 2; Non-ketamine-using drug user with psychotic disorders	Diagnostic test: genome testing; blood sampling via venipuncture
Control Group 3; Non-ketamine-using drug user without psychotic disorders ( identified from register-based medical record system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Albert KK Chung, MBBS(HK), The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 25, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: SToP-K_CC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No