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Substance Misuse To Psychosis for Ketamine (SToP-K)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485339
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Albert Kar-Kin Chung, The University of Hong Kong

Tracking Information
First Submitted Date March 19, 2018
First Posted Date April 2, 2018
Last Update Posted Date July 31, 2020
Actual Study Start Date June 12, 2018
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2018)
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
Original Primary Outcome Measures
 (submitted: March 25, 2018)
relative risk of ketmaine users compared to non-ketamine using drug user to develop psychosis [ Time Frame: During the 2 year study period ]
relative risk of ketmaine users compared to non-ketamine using drug user to develop psychosis
Change History
Current Secondary Outcome Measures
 (submitted: March 30, 2018)
Gene association to development of psychcosis [ Time Frame: During the 2 year study period ]
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
Original Secondary Outcome Measures
 (submitted: March 25, 2018)
Gene association to development of psychcosis [ Time Frame: During the 2 year study period ]
The single nucleotide polymorphism of 4 genes associated with NMDR receptor and dopamine receptor being associated with the development of psychosis in ketamine abuser
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ketamine abuser and non-ketamine-using drug abusers
Condition
  • Ketamine Abuse
  • Psychotic Disorders
  • Substance Use Disorders
  • Schizophrenia
  • Genetic Predisposition
Intervention Diagnostic Test: genome testing
blood sampling via venipuncture
Study Groups/Cohorts
  • Case
    Ketamine user with psychotic disorders
    Intervention: Diagnostic Test: genome testing
  • Control Group 1
    Ketamine user without psychotic disorders
    Intervention: Diagnostic Test: genome testing
  • Control Group 2
    Non-ketamine-using drug user with psychotic disorders
    Intervention: Diagnostic Test: genome testing
  • Control Group 3
    Non-ketamine-using drug user without psychotic disorders ( identified from register-based medical record system)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 30, 2020)
162
Original Estimated Enrollment
 (submitted: March 25, 2018)
150
Actual Study Completion Date April 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT03485339
Other Study ID Numbers SToP-K_CC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Dr. Albert Kar-Kin Chung, The University of Hong Kong
Original Responsible Party Same as current
Current Study Sponsor The University of Hong Kong
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: albert KK Chung, MBBS(HK) The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date July 2020