Substance Misuse To Psychiatric Disorders for Cannabis

NCT ID: NCT03485274

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2023-04-30

Brief Summary

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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

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Conditions

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Cannabis Use Disorder Depressive State Anxiety State Depression Anxiety Disorders Pharmacotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomised single-blinded
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
treatment in each intervention arms is masked to the outcome assessor

Study Groups

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Vortioxetine Arm

Oral: 5-20mg daily

Group Type ACTIVE_COMPARATOR

Vortioxetine

Intervention Type DRUG

oral medication taken once daily

Treatment as Usual

Any medication or Rx other than vortixoetine

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type OTHER

Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine

Interventions

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Vortioxetine

oral medication taken once daily

Intervention Type DRUG

Treatment as Usual

Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Albert Kar-Kin Chung

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert KK Chung, MBBS(HK)

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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SToP-C

Identifier Type: -

Identifier Source: org_study_id

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