NCT04373525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

April 23, 2020

Last Update Submit

March 24, 2026

Conditions

Keywords

CannabisCognitionGenetics

Outcome Measures

Primary Outcomes (4)

  • Montreal Cognitive Assessment

    Subject assessed with a maximum score of 30. Those who score 26 or below will consider to have mild cognitive impairment

    18 months

  • Frontal Assessment Battery

    Subject who scores 12 or below will be considered having frontal dysexcutive function

    18 months

  • Wechsler Memory Scale

    Subject will be assessed with the scale for their immediate, delayed, visual and auditory memory

    18 months

  • Genome analysis

    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

    Each subject only need to have venous blood test once 1 day within their 18-months study period

Interventions

Venous blood will be obtained for later genome analysis

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

16-60 years old cannabis users

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

venous blood sample

MeSH Terms

Conditions

Cognition DisordersGenetic Predisposition to DiseaseMarijuana Abuse

Interventions

Genome-Wide Association Study

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesMolecular EpidemiologyGenetic Association StudiesGenetic TechniquesOligonucleotide Array Sequence AnalysisSequence AnalysisPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

April 23, 2020

First Posted

May 4, 2020

Study Start

November 1, 2020

Primary Completion

August 31, 2025

Study Completion

December 31, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

data without identifiable

Locations