Substance Misuse To Psychosis for Ketamine (SToP-K)

Ketamine

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.

Intervention / Treatment

  • genome testing (DIAGNOSTIC_TEST)
    blood sampling via venipuncture

Condition or Disease

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

Phase

Study Design

Study type: OBSERVATIONAL
Status: Completed
Study results: No Results Available
Age: 12 Years to 65 Years
Enrollment: 162 (ACTUAL)
Funded by: Other
Time Perspective: Other
Observational Model: Case-Control

Masking

Clinical Trial Dates

Start date: Jun 12, 2018 ACTUAL
Primary Completion: Mar 01, 2020 ACTUAL
Completion Date: Apr 01, 2020 ACTUAL
Study First Posted: Apr 02, 2018 ACTUAL
Results First Posted: Aug 31, 2020
Last Updated: Jul 30, 2020

Sponsors / Collaborators

Lead Sponsor: The University of Hong Kong
Responsible Party: N/A

Location

Hong Kong, China

Participant Groups

  • Ketamine user with psychotic disorders

  • Ketamine user without psychotic disorders

  • Non-ketamine-using drug user with psychotic disorders

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

Eligibility Criteria

Sex: All
Minimum Age: 12
Maximum Age: 65
Age Groups: Child / Adult / Older Adult
Healthy Volunteers: Yes

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

Primary Outcomes

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

Secondary Outcomes

  • 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

More Details

NCT Number: NCT03485339
Other IDs: SToP-K_CC
Study URL: https://clinicaltrials.gov/study/NCT03485339
Last updated: Sep 29, 2023