Change in Cognitive Function in Stimulant Users

Substance Use Clinical Trial

— SToP-S_CogFx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04061941
• Other study ID #: BDF180058
• Status: Recruiting
• Start date: October 21, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: The University of Hong Kong
• Contact: albert KK Chung, MBBS(HK)
• Phone: 2255 4486
• Email: chungkka[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use
• Cognitive Dysfunction
• Methamphetamine Abuse
• Stimulant Use
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Cognitive Assessment
Assessment on cognitive dysfunction using standardised cognitive tests

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Beat Drugs Fund Association

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment	Measure the change in global cognitive function	12 months
Primary	Frontal Assessment Battery	Measure the change in executive function	12 months
Primary	Diagnostic and Statistical Manual of mental disorders 5th edition (DSM-5 )severity of stimulant use disorder	To determine different severity of stimulant use	12 months
Secondary	Frequency of stimulant use		12 months