search
Back to results

Substance Misuse To Psychiatric Disorders for Cannabis

Primary Purpose

Cannabis Use Disorder, Depressive State, Anxiety State

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Vortioxetine
Treatment as Usual
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Cannabis, depression, anxiety, medication

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vortioxetine Arm

Treatment as Usual

Arm Description

Oral: 5-20mg daily

Any medication or Rx other than vortixoetine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

prevalence of Cannabis induced mood disorder
The prevalence of the cannabis induced disorder in both arms
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
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
Change in cognitive outcome
To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms

Full Information

First Posted
March 14, 2018
Last Updated
July 2, 2023
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT03485274
Brief Title
Substance Misuse To Psychiatric Disorders for Cannabis
Official Title
Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Depressive State, Anxiety State, Depression, Anxiety Disorders, Pharmacotherapy
Keywords
Cannabis, depression, anxiety, medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
prospective randomised single-blinded
Masking
Outcomes Assessor
Masking Description
treatment in each intervention arms is masked to the outcome assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine Arm
Arm Type
Active Comparator
Arm Description
Oral: 5-20mg daily
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Any medication or Rx other than vortixoetine
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
oral medication taken once daily
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine
Primary Outcome Measure Information:
Title
change in severity of Cannabis Use Disorder (CUD)
Description
Change in severity of the cannabis use disorder for the 2 arms as defined by DSM-5
Time Frame
6 months
Secondary Outcome Measure Information:
Title
prevalence of Cannabis induced mood disorder
Description
The prevalence of the cannabis induced disorder in both arms
Time Frame
6 months
Title
Change in Hamilton anxiety (HAM-A) rating scale
Description
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
Time Frame
6 months
Title
Change in Hamilton depression (HAM-D) rating scale
Description
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
Time Frame
6 months
Title
Change in cognitive outcome
Description
To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert KK Chung, MBBS(HK)
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Substance Misuse To Psychiatric Disorders for Cannabis

We'll reach out to this number within 24 hrs