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CompletedN/A

Substance Misuse To Psychosis for Ketamine (SToP-K)

NCT03485339 · The University of Hong Kong

Closed to entry
Status
Not accepting participants
Not applicable
Phase
162
Target enrolment
2
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over During the 2 year study period

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

12 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

2 study sites

FacilityCityRegionCountry
Queen Mary HospitalHong KongHong Kong
Western Psychiatric CentreHong KongHong Kong

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03485339 on ClinicalTrials.gov →

Last updated in the registry 2020-07-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits