Substance Misuse To Psychiatric Disorders for Cannabis | NCT03485274

Studies
Substance Misuse To Psychiatric Disorders for Cannabis

NCT03485274

Sponsor

The University of Hong Kong

Status

Completed

Last Update Posted

Jul 5, 2023Actual

Enrollment

37Actual

Phase

Phase 2Phase 3

Conditions

Cannabis Use Disorder
Depressive State
Anxiety State
Depression
Anxiety Disorders
Pharmacotherapy

Interventions

Vortioxetine
Treatment as Usual

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2018Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Mar 14, 2018

First Submission Date that Met QC Criteria

Mar 25, 2018

First Posted Date

Apr 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2023

Last Update Posted Date

Jul 5, 2023Actual

Name	Class
Queen Mary Hospital, Hong Kong	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With the recent availability of vortioxetine, and the surging phenomenon of cannabis misuses amongst young abusers, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with cannabis use disorders with depressive or anxiety symptoms, to develop into a more chronic disabling dependence or co-morbid state.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vortioxetine Arm	Active Comparator	Oral: 5-20mg daily	Drug: Vortioxetine
Treatment as Usual	Active Comparator	Any medication or Rx other than vortixoetine	Other: Treatment as Usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vortioxetine	Drug	oral medication taken once daily	Vortioxetine Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in severity of Cannabis Use Disorder (CUD)	Change in severity of the cannabis use disorder for the 2 arms as defined by DSM-5	6 months

Secondary Outcomes

Measure	Description	Time Frame
prevalence of Cannabis induced mood disorder	The prevalence of the cannabis induced disorder in both arms	6 months
Change in Hamilton anxiety (HAM-A) rating scale	To assess the change of anxiety severity of the two treatment arms using HAM-A for both treatment arms with cut-off of defining anxiety >=14

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms

Exclusion Criteria:

Age <16 years old
Unable to read English or Chinese
Unable to give informed consent
Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation
Had history of primary psychotic episode
Had been diagnosed to have substance-induced mood disorder, other than cannabis
Had been diagnosed to have mood disorders or anxiety disorders
Had been taking maintenance therapeutic dose of antidepressant continuously >= 6 months AND with depressive symptom or anxiety symptom being in remission
Had known hypersensitivity to vortioxetine
Had known history of serotonin syndrome
Pregnant
Mother currently breast-feeding
Currently taking warfarin and/or having poorly controlled bleeding disorder
Had history of prolonged QTc ≥500ms and/or known unstable or untreated cardiology disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Albert KK Chung, MBBS(HK)	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital		Hong Kong		000000	Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001008	Anxiety Disorders
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders
D019966	Substance-Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078784	Vortioxetine
D013812	Therapeutics

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided