Substance Misuse To Psychiatric Disorders for Cannabis

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485274
• Other study ID #: SToP-C
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 25, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: July 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Cannabis Use Disorder
• Depression
• Depressive State
• Marijuana Abuse
• Mental Disorders
• Pharmacotherapy
• Problem Behavior

Intervention

Drug:
• Vortioxetine
oral medication taken once daily

Other:
• Treatment as Usual
Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	prevalence of Cannabis induced mood disorder	The prevalence of the cannabis induced disorder in both arms	6 months
Secondary	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
Secondary	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
Secondary	Change in cognitive outcome	To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms	6 months