Substance Misuse To Psychosis for Ketamine (SToP-K)

NCT ID: NCT03485339

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-12

Study Completion Date

2020-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ketamine Abuse Psychotic Disorders Substance Use Disorders Schizophrenia Genetic Predisposition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case

Ketamine user with psychotic disorders

genome testing

Intervention Type DIAGNOSTIC_TEST

blood sampling via venipuncture

Control Group 1

Ketamine user without psychotic disorders

genome testing

Intervention Type DIAGNOSTIC_TEST

blood sampling via venipuncture

Control Group 2

Non-ketamine-using drug user with psychotic disorders

genome testing

Intervention Type DIAGNOSTIC_TEST

blood sampling via venipuncture

Control Group 3

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

genome testing

blood sampling via venipuncture

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Albert Kar-Kin Chung

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

albert KK Chung, MBBS(HK)

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Western Psychiatric Centre

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SToP-K_CC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endogenous Opioid Modulation by Ketamine
NCT03051945 WITHDRAWN PHASE3
Ketamine for Low Mood States in the ER
NCT01209845 COMPLETED PHASE1
Cannabinoids, Learning, and Memory
NCT02407808 ACTIVE_NOT_RECRUITING PHASE1
Ketamine For Suicidal Ideation
NCT01507181 COMPLETED PHASE4
Cognitive Biases Under Ketamine
NCT02235012 COMPLETED NA
Methamphetamine and Troriluzole
NCT06989853 RECRUITING EARLY_PHASE1