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Change in Cognitive Function in Stimulant Users (SToP-S_CogFx)

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ClinicalTrials.gov Identifier: NCT04061941
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Beat Drugs Fund Association
Information provided by (Responsible Party):
Dr. Albert Kar-Kin Chung, The University of Hong Kong

Tracking Information
First Submitted Date August 16, 2019
First Posted Date August 20, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date October 21, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2019)
  • Montreal Cognitive Assessment [ Time Frame: 12 months ]
    Measure the change in global cognitive function
  • Frontal Assessment Battery [ Time Frame: 12 months ]
    Measure the change in executive function
  • Diagnostic and Statistical Manual of mental disorders 5th edition (DSM-5 )severity of stimulant use disorder [ Time Frame: 12 months ]
    To determine different severity of stimulant use
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2019)
Frequency of stimulant use [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Change in Cognitive Function in Stimulant Users
Official Title A Prospective Study to Evaluate the Change in Cognitive Function in Stimulant Users
Brief Summary

In Hong Kong, methamphetamine use is common and cocaine use has increased steadily over the past few years. While the use of ketamine decreased from 35.8% in 2015 to 13.9% in 2017, methamphetamine and cocaine have become the most commonly used psychotropic substances and account for more than 50% of drug abuses cases in 2017. Among all stimulants, methamphetamine is most commonly used because it releases three times more dopamine than cocaine and the effects can last from eight to twelve hours, compared to two hours for cocaine. On top of its extreme effects, methamphetamine is relatively inexpensive, making it even more accessible to the young population.

Misuse of methamphetamine has long been associated with profound psychological and cognitive disturbance. In reviewing the cognitive data from reasonably well-matched groups of chronic methamphetamine users and healthy controls, the majority of studies have found that chronic methamphetamine users had lower scores on at least some cognitive tests, although some studies are exceptions with entirely nonsignificant differences. A meta-analysis of 17 cross-sectional studies found that chronic methamphetamine users demonstrated significantly lower cognitive scores than healthy controls. The effects were largest for measures of learning, executive functions, memory, and processing speed, although the majority of cognitive domains significantly differed between the groups.

Concerns has been emerging regarding the methodology of the aforementioned results. In particular, the appropriateness of using healthy controls to examine the cognitive effects of stimulant use has been questioned. Much of the published research has fallen victim to using controls with significant baseline differences from the chronic stimulant users, such as years of education. In addition, none of the studies available provided scatter plots of their cognitive data to evaluate the overlap in performance between chronic stimulant users and healthy controls. In fact, many chronic stimulant users have normal cognitive function when compared with normative data. Therefore, the use of the term 'impairment' or 'deficit' in many studies is not fully justified. Another limitation is that it cannot differentiate cognitive weaknesses that may predate stimulant use from those that result from it. Notably, longitudinal studies have shown that childhood deficits in executive function can predict drug abuse in adolescence, suggesting that at least some of the cognitive weaknesses pre-exist in chronic stimulant user. These and other limitations provoked a conclusion that the evidence for cognitive deficits in chronic stimulant users is weak.

In order to overcome the methodological issues observed in previous cross-sectional studies, we propose to conduct a prospective studies to determine the change in cognitive function among stimulant users over time.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population stimulant users who have been taking stimulants regularly
Condition
  • Cognitive Dysfunction
  • Stimulant Use
  • Methamphetamine Abuse
  • Cocaine Use
  • Substance Use
Intervention Behavioral: Cognitive Assessment
Assessment on cognitive dysfunction using standardised cognitive tests
Study Groups/Cohorts Stimulant Users
Stimulant users that fulfill SCID-5 clinician version definition for assessment on stimulant use disorder under DSM-5
Intervention: Behavioral: Cognitive Assessment
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 Recruiting
Estimated Enrollment
 (submitted: August 19, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2022
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age: 18 - 65 years old at the time of enrolment
  • Able to read and communicate in English and/or Chinese
  • Able to give informed consent
  • Using stimulants as the primary psychoactive substance of abuse
  • "Repeated" and "Active" stimulant users as defined by Structured Clinical Interview for DSM-5 Disorders (SCID-5)

Exclusion Criteria:

  • Age <18 years old
  • Unable to read English or Chinese
  • Unable to give informed consent
  • Had been diagnosed with other Substance Use or Related Disorders with severity ≥4 according to DSM-5, or other psychoactive substance dependence syndrome according to International Classification of Disease (ICD-10)
  • Currently taking regular prescribed psychiatric medications, including antipsychotics, antidepressants, mood stabilizers, anti-epileptics, benzodiazepines, hypnotics, and anti-cholinergic medications.
  • Had been diagnosed with other DSM-5 disorders including:

    • Neurodevelopmental Disorders
    • Schizophrenia Spectrum and Other Psychotic Disorders
    • Bipolar and Related Disorders
    • Depressive Disorders, Anxiety Disorders, and Obsessive-Compulsive and Related Disorders
    • Dissociative Disorders, Somatic Symptoms and Related Disorders
    • Feeding and Eating Disorders
    • Sleep-wake Disorders
    • Neurocognitive Disorders
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: albert KK Chung, MBBS(HK) 2255 4486 chungkka@hku.hk
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT04061941
Other Study ID Numbers BDF180058
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Responsible Party Dr. Albert Kar-Kin Chung, The University of Hong Kong
Study Sponsor The University of Hong Kong
Collaborators Beat Drugs Fund Association
Investigators Not Provided
PRS Account The University of Hong Kong
Verification Date November 2020