Substance Misuse To Psychiatric Disorders for Cannabis

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pharmacotherapy; Depressive State; Cannabis Use Disorder; Depression; Anxiety Disorders; Anxiety State

Treatments: Drug: Vortioxetine; Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03485274

SToP-C

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Vortioxetine Arm

Active Comparator group

Description:

Oral: 5-20mg daily

Treatment:

Drug: Vortioxetine

Treatment as Usual

Active Comparator group

Description:

Any medication or Rx other than vortixoetine

Treatment:

Other: Treatment as Usual