Substance Misuse To Psychiatric Disorders for Cannabis

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorders; Anxiety State; Cannabis Use Disorder; Pharmacotherapy; Depressive State
• Intervention / Treatment: Drug: Vortioxetine; Other: Treatment as Usual

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Albert KK Chung, MBBS; Email: stop.hku@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Queen Mary Hospital, Hong Kong
• Investigators: Principal Investigator: Albert KK Chung, MBBS(HK), The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2018
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 25, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: depression; medication; anxiety; Cannabis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Chemically-Induced Disorders; Substance-Related Disorders; Depression; Problem Behavior; Anxiety Disorders; Mental Disorders; Marijuana Abuse; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Selective Serotonin Reuptake Inhibitors; Vortioxetine
• Other Study ID Numbers: SToP-C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes