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Cognitive DysfunctionSToP-S_CogFxNCT04061941

Change in Cognitive Function in Stimulant Users

An observational study of Cognitive Dysfunction and Stimulant Use, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Cognitive Assessment
How many people
93 participants
Where
1 siteHong Kong
Study dates
21 Oct 2019to 31 Dec 2023
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: stimulant users who have been taking stimulants regularly

Who may be able to join

  • 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)

Who cannot join

  • 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:
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Queen Mary Hospital

    Hong Kong, 000000

Other trials in Hong Kong

About this study

Official title: A Prospective Study to Evaluate the Change in Cognitive Function in Stimulant Users

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.

Read more

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.

Being tested
Cognitive Assessment
Medical subject headings
Cognitive Dysfunction, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive AssessmentBehavioural

    Assessment on cognitive dysfunction using standardised cognitive tests

Study groups in NCT04061941
Study groupRoleWhat they receive
Stimulant UsersStimulant users that fulfill SCID-5 clinician version definition for assessment on stimulant use disorder under DSM-5
Receives: Behavioral: Cognitive Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment

    Measure the change in global cognitive function

    Measured: 12 months

  2. Frontal Assessment Battery

    Measure the change in executive function

    Measured: 12 months

  3. Diagnostic and Statistical Manual of mental disorders 5th edition (DSM-5 )severity of stimulant use disorder

    To determine different severity of stimulant use

    Measured: 12 months

Secondary outcomes (1)
  1. Frequency of stimulant use

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2019
  2. Study start21 Oct 2019
  3. Primary completion31 May 2023
  4. Study completion31 Dec 2023

Resources

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
Cohort
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04061941
Sponsor's protocol ID
BDF180058
Acronym
SToP-S_CogFx
Status last verified
May 2024
First submitted
16 Aug 2019
Last updated
24 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Dysfunction and Stimulant Use, run by The University of Hong Kong at 1 site 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 14 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 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Montreal Cognitive Assessment (time frame: 12 months). The study lists 3 primary outcomes in all. 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 24 May 2024.

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