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.
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
- Conditions the study is for
- Cognitive Dysfunction, Stimulant Use, Methamphetamine Abuse
- What is being tested?
- Cognitive Assessment
- Type of treatment
- Lifestyle or therapy programme
- 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:
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- 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.
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 group | Role | What they receive |
|---|---|---|
| Stimulant Users | Stimulant 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.
Montreal Cognitive Assessment
Measure the change in global cognitive function
Measured: 12 months
Frontal Assessment Battery
Measure the change in executive function
Measured: 12 months
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)
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.
- First posted20 Aug 2019
- Study start21 Oct 2019
- Primary completion31 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Beat Drugs Fund Association
- Responsible party
- Principal investigator, Dr. Albert Kar-Kin Chung, The University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Change in Cognitive Function in Stimulant Users
- ClinicalTrials.gov ID
- NCT04061941
- Acronym / sponsor ID
- SToP-S_CogFx / BDF180058
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Beat Drugs Fund Association
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Aug 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulant Users | – | Behavioral: Cognitive AssessmentStimulant users that fulfill SCID-5 clinician version definition for assessment on stimulant use disorder under DSM-5 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stimulant users who have been taking stimulants regularly
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Cognitive AssessmentAssessment on cognitive dysfunction using standardised cognitive tests | Behavioural | Stimulant Users |
Primary outcome
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
1 secondary outcome
Frequency of stimulant use
Time frame: 12 months
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 24 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.