Substance Misuse To Psychiatric Disorders for Cannabis

Phase 2

Completed

• Conditions: Depression; Anxiety Disorders; Pharmacotherapy; Cannabis Use Disorder; Depressive State; Anxiety State
• Interventions: Drug: Vortioxetine; Other: Treatment as Usual

• Registration Number: NCT03485274
• Lead Sponsor: The University of Hong Kong

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 available

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-25
• Study First Posted: 2018-04-02
• Study Start: 2018-07-25
• Primary Completion: 2023-02-28
• Study Completion: 2023-04-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-02
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vortioxetine Arm	Vortioxetine	Oral: 5-20mg daily
Treatment as Usual	Treatment as Usual	Any medication or Rx other than vortixoetine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
prevalence of Cannabis induced mood disorder	6 months	The prevalence of the cannabis induced disorder in both arms
Change in Hamilton anxiety (HAM-A) rating scale	6 months	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
Change in Hamilton depression (HAM-D) rating scale	6 months	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
Change in cognitive outcome	6 months	To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong