SToP-C_PeCoG: Prospective Evaluation on Cognitive Function and Its Associated Genetic Vulnerability in Cannabis Users

Sponsor

The University of Hong Kong (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04373525

Collaborator

(none)

136

Enrollment

Location

40.9

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Most of the studies assessing Cannabis Use Disorder (CUD) and neurocognitive functions are cross-sectional without examining the longitudinal changes in neurocognitive function at a within-subject level with respect to the continuum of cannabis use behavior, or mainly studying on the acute cannabis effect. As for the Genome-wide Association studies, the population analyzed for addressing the underlying genetic susceptibility between neurocognitive functions and/or cannabis use or CUD were almost exclusively based on African- or European- American samples or other Caucasian subjects, and thus generalizability to Chinese or to the non-Caucasian population definitely demands more studies.

With the upsweeping statistical figures of cannabis use in Hong Kong and Asia, and the substantial falls in the perceived risk and personal disapproval from using cannabis amongst young abusers, coinciding the global advocacy of de-criminalizing cannabis and the increased availability of recreational cannabis worldwide, it is reasonable to predict that there will be a further upsurge in numbers of all aged cannabis users in Hong Kong as in the other part of the world. Therefore, the SToP-C-PeCoG study proposed here as a prospective study in assessing the longer term changes in neurocognitive functions and the associated genetic risks for those repeated and active cannabis users without psychiatric co-morbidity is definitely warranted. The PeCoG study will not only provide the scientific evidence to further unveil the harmful effects on neurocognitive functions for those self-perceived "healthy" users, but also help to raise the public awareness and to improve the understandings to the long-term detrimental effects of cannabis amongst users and non-users. Furthermore, it will provide a chance to study the associated genetic risks for cannabis abusers, in particular in the Asian minority and Chinese, on CUD and poorer neurocognitive outcomes, with genetic vulnerability being generalizable to the local population in Asia.

The current study hypothesises that cannabis abusers have neurocognitive function decline over time, and genetic vulnerability is associated with cannabis abusers who have poorer neurocognitive outcomes or with the severity of CUD.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Use Neurocognitive Dysfunction Genetic Predisposition	Other: Genome analysis

Study Design

Study Type:

Observational

Anticipated Enrollment :

136 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Substance Misuse To Psychiatric Disorders for Cannabis-Prospective Evaluation on Cognitive Function and Its Associated Genetic Vulnerability in Cannabis Users (SToP-C-PeCoG)

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Outcome Measures

Primary Outcome Measures

Montreal Cognitive Assessment [18 months]
Subject assessed with a maximum score of 30. Those who score 26 or below will consider to have mild cognitive impairment
Frontal Assessment Battery [18 months]
Subject who scores 12 or below will be considered having frontal dysexcutive function
Wechsler Memory Scale [18 months]
Subject will be assessed with the scale for their immediate, delayed, visual and auditory memory
Genome analysis [Each subject only need to have venous blood test once 1 day within their 18-months study period]
venous blood test will be done on consented subject for genome analysis for associated single nucleotide polymorphisms on 4 related chromosomes identified from literature associated with cannabis use disorder and neurocognitive impairment

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age: 16 - 60 years old at the time of enrolment
Able to read and communicate in English and/or Chinese
Able to give informed consent
Using cannabis or marijuana as the primary psychoactive substance of abuse
Repeated and Active cannabis users as defined by Structured Clinical Interview for DSM-5 Disorders

Exclusion Criteria:

Age <16 years old
Unable to read English or Chinese
Unable to give informed consent
Had been diagnosed with other Substance Related Disorders, except for Tobacco Use Disorders due to the known frequent comorbid use for cannabis users (12)
Currently taking regular prescribed psychiatric medications, including antipsychotics, antidepressants, mood stabilizers, anti-epileptics, benzodiazepines, hypnotics, and anti-cholinergic medications.
Had been diagnosed with DSM-5 disorders, other than Cannabis Use and related disorders