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CompletedNCT03485339Updated Jul 31, 2020

Substance Misuse To Psychosis for Ketamine (SToP-K)

An observational study in Ketamine Abuse, Psychotic Disorders and Substance Use Disorders, sponsored by The University of Hong Kong. Completed at 2 sites in Hong Kong. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-31.

Sponsored by The University of Hong Kong · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
162
Ages
12 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ketamine Abuse
  • Psychotic Disorders
  • Substance Use Disorders
  • Schizophrenia
  • Genetic Predisposition
03

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ketamine abuser and non-ketamine-using drug abusers

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

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
04

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
162 participants (actual)
Patient registry
No

Groups and cohorts

  • Case

    Ketamine user with psychotic disorders

    Diagnostic Test: genome testing

  • Control Group 1

    Ketamine user without psychotic disorders

    Diagnostic Test: genome testing

  • Control Group 2

    Non-ketamine-using drug user with psychotic disorders

    Diagnostic Test: genome testing

  • Control Group 3

    Non-ketamine-using drug user without psychotic disorders ( identified from register-based medical record system)

Interventions

  • Diagnostic testgenome testing

    blood sampling via venipuncture

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: During the 2 year study period

Secondary outcomes

  1. 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

    Time frame: During the 2 year study period

06

Study locations

2 sites
  • Queen Mary Hospital
    Hong Kong, 000000, Hong Kong
  • Western Psychiatric Centre
    Hong Kong, 00000, Hong Kong
07

Registry details

Key details

Study ID
NCT03485339
Lead sponsor
The University of Hong Kong
Responsible party
Dr. Albert Kar-Kin Chung (Clinical Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Apr 2, 2018
Start date
Jun 12, 2018
Primary completion
Mar 1, 2020
Completion
Apr 1, 2020
Last update
Jul 31, 2020

Study contacts

albert KK Chung, MBBS(HK)
principal investigator · The University of Hong Kong

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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