Cannabis Use DisorderPhase 2/3NCT03485274
Substance Misuse To Psychiatric Disorders for Cannabis
A Phase 2/3 study testing Vortioxetine and Treatment as Usual in people with Cannabis Use Disorder and Depressive State, run by The University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Cannabis Use Disorder, Depressive State, Anxiety State
- What is being tested?
- Vortioxetine and Treatment as Usual
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Jul 2018to 30 Apr 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cannabis Use Disorder, Depressive State, Anxiety State, Depression, Anxiety Disorders, Pharmacotherapy
- Being tested
- Vortioxetine, Treatment as Usual
- Keywords
- Cannabis, depression, anxiety, medication
- Medical subject headings
- Depression, Anxiety Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
oral medication taken once daily
Treatment as UsualOther
Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine Arm | Active comparator | Oral: 5-20mg daily Receives: Drug: Vortioxetine |
| Treatment as Usual | Active comparator | Any medication or Rx other than vortixoetine Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
prevalence of Cannabis induced mood disorder
The prevalence of the cannabis induced disorder in both arms
Measured: 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
Measured: 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
Measured: 6 months
Change in cognitive outcome
To assess the change in cognitive outcome using Frontal Assessment Battery in the two treatment arms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start25 Jul 2018
- Primary completion28 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomised single-blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Dr. Albert Kar-Kin Chung, The University of Hong Kong
- Investigators
- Albert KK Chung, MBBS(HK), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485274
- Sponsor's protocol ID
- SToP-C
- Status last verified
- Jul 2023
- First submitted
- 14 Mar 2018
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study
- ClinicalTrials.gov ID
- NCT03485274
- Acronym / sponsor ID
- SToP-C
- Conditions
- Cannabis Use Disorder, Depressive State, Anxiety State, Depression, Anxiety Disorders, Pharmacotherapy
- Keywords
- Cannabis, depression, anxiety, medication
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomised single-blinded
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine Arm | Active comparator | Drug: VortioxetineOral: 5-20mg daily |
| Treatment as Usual | Active comparator | Other: Treatment as UsualAny medication or Rx other than vortixoetine |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetineoral medication taken once daily | Drug | Vortioxetine Arm |
| Treatment as UsualAny pharmacological or non-pharmacotherapy modalities other than use of vortioxetine | Other | Treatment as Usual |
Primary outcome
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
4 secondary outcomes
prevalence of Cannabis induced mood disorder
Time frame: 6 months
Change in Hamilton anxiety (HAM-A) rating scale
Time frame: 6 months
Change in Hamilton depression (HAM-D) rating scale
Time frame: 6 months
Change in cognitive outcome
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
Related trials for Cannabis Use Disorder
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert KK Chung, MBBS(HK) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vortioxetine and Treatment as Usual in people with Cannabis Use Disorder and Depressive State, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity of Cannabis Use Disorder (CUD) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.