Clinical trial NCT03485339: Substance Misuse To Psychosis for Ketamine (SToP-K)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ketamine Abuse
Psychotic Disorders
Substance Use Disorders
Schizophrenia
Genetic Predisposition
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 162
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ketamine abuser and non-ketamine-using drug abusers

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.


Eligibility criteria: 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:
measure: relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis
timeFrame: During the 2 year study period
Secondary outcomes:
measure: Gene association to development of psychcosis
timeFrame: During the 2 year study period
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Western Psychiatric Centre
Study officials:
affiliation: The University of Hong Kong
name: albert KK Chung, MBBS(HK)
role: PRINCIPAL_INVESTIGATOR
References: