Substance Misuse To Psychiatric Disorders for Cannabis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03485274
Recruitment Status : Not yet recruiting
First Posted : April 2, 2018
Last Update Posted : May 18, 2018
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
Dr. Albert Kar-Kin Chung, 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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Depressive State Anxiety State Depression Anxiety Disorders Pharmacotherapy Drug: Vortioxetine Other: Treatment as Usual Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomised single-blinded
Masking: Single (Outcomes Assessor)
Masking Description: treatment in each intervention arms is masked to the outcome assessor
Primary Purpose: Treatment
Official Title: Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study
Estimated Study Start Date : May 29, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Marijuana

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

Primary Outcome Measures :
  1. change in severity of Cannabis Use Disorder (CUD) [ Time Frame: 6 months ]
    Change in severity of the cannabis use disorder for the 2 arms as defined by DSM-5

Secondary Outcome Measures :
  1. prevalence of Cannabis induced mood disorder [ Time Frame: 6 months ]
    The prevalence of the cannabis induced disorder in both arms

  2. Change in Hamilton anxiety (HAM-A) rating scale [ Time Frame: 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

  3. Change in Hamilton depression (HAM-D) rating scale [ Time Frame: 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

  4. Change in cognitive outcome [ Time Frame: 6 months ]
    To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 any antidepressant continuously ≥2 weeks
  • 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

Responsible Party: Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong Identifier: NCT03485274     History of Changes
Other Study ID Numbers: SToP-C
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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

Keywords provided by Dr. Albert Kar-Kin Chung, The University of Hong Kong:

Additional relevant MeSH terms:
Anxiety Disorders
Marijuana Abuse
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists