Ketamine AbuseNCT03485339
Substance Misuse To Psychosis for Ketamine (SToP-K)
An observational study of Ketamine Abuse and Psychotic Disorders, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Ketamine Abuse, Psychotic Disorders, Substance Use Disorders
- What is being tested?
- genome testing
- How many people
- 162 participants
- Where
- 2 sitesHong Kong
- Study dates
- 12 Jun 2018to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ketamine abuser and non-ketamine-using drug abusers
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong, 000000
Western Psychiatric Centre
Hong Kong, 00000
About this study
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
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.
- Conditions
- Ketamine Abuse, Psychotic Disorders, Substance Use Disorders, Schizophrenia, Genetic Predisposition
- Being tested
- genome testing
- Medical subject headings
- Psychotic Disorders, Substance-Related Disorders, Schizophrenia, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genome testingDiagnostic test
blood sampling via venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Case | Ketamine user with psychotic disorders Receives: Diagnostic Test: genome testing | |
| Control Group 1 | Ketamine user without psychotic disorders Receives: Diagnostic Test: genome testing | |
| Control Group 2 | Non-ketamine-using drug user with psychotic disorders Receives: Diagnostic Test: genome testing | |
| Control Group 3 | Non-ketamine-using drug user without psychotic disorders ( identified from register-based medical record system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During the 2 year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start12 Jun 2018
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketamine AbuseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Albert Kar-Kin Chung, The University of Hong Kong
- Investigators
- albert KK Chung, MBBS(HK), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485339
- Sponsor's protocol ID
- SToP-K_CC
- Status last verified
- Jul 2020
- First submitted
- 19 Mar 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03485339
- Acronym / sponsor ID
- SToP-K_CC
- Conditions
- Ketamine Abuse, Psychotic Disorders, Substance Use Disorders, Schizophrenia, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: genome testingKetamine user with psychotic disorders |
| Control Group 1 | – | Diagnostic Test: genome testingKetamine user without psychotic disorders |
| Control Group 2 | – | Diagnostic Test: genome testingNon-ketamine-using drug user with psychotic disorders |
| Control Group 3 | – | –Non-ketamine-using drug user without psychotic disorders ( identified from register-based medical record system) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ketamine abuser and non-ketamine-using drug abusers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genome testingblood sampling via venipuncture | Diagnostic test | Case, Control Group 1, Control Group 2 |
Primary outcome
relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis
Time frame: During the 2 year study period
relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis
1 secondary outcome
Gene association to development of psychcosis
Time frame: During the 2 year study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
albert KK Chung, MBBS(HK) principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ketamine Abuse and Psychotic Disorders, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative risk of ketamine users compared to non-ketamine using drug user to develop psychosis (time frame: During the 2 year study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.