Substance Misuse To Psychiatric Disorders for Cannabis

Study Overview
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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.

Official Title
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Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study

Conditions
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Cannabis Use Disorder, Depressive State, Anxiety State, Depression, Anxiety Disorders, Pharmacotherapy

Intervention / Treatment
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* Drug: Vortioxetine
* Other: Treatment as Usual


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomised single-blinded
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vortioxetine Arm<br>Oral: 5-20mg daily | Drug: Vortioxetine<br>* oral medication taken once daily<br>|
| Active Comparator: Treatment as Usual<br>Any medication or Rx other than vortixoetine | Other: Treatment as Usual<br>* Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 6 months | 
| Change in Hamilton depression (HAM-D) rating scale | To assess the change of depression severity of the two treatment arms using HAM-D for both treatment arms with cut-off of defining depression >=8 | 6 months | 
| Change in cognitive outcome | To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis, depression, anxiety, medication