Skip to main content
OpenTrials
Completed

NCT Number: NCT03485274

Substance Misuse To Psychiatric Disorders for Cannabis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cannabis Use Disorder Anxiety Disorders Anxiety State Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Depressive State Marijuana Abuse Mental Disorders Pharmacotherapy Substance-Related Disorders

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Queen Mary Hospital

Hong Kong, 000000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vortioxetine

Drug

oral medication taken once daily

Treatment as Usual

Other

Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Queen Mary Hospital, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 2, 2018
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.