Substance Misuse To Psychiatric Disorders for Cannabis (SToP-C)--an Early Assertive Pharmacotherapy Intervention Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- change in severity of Cannabis Use Disorder (CUD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
treatment in each intervention arms is masked to the outcome assessor
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms
排除标准
- •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
- •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
研究组 & 干预措施
Vortioxetine Arm
Oral: 5-20mg daily
干预措施: Vortioxetine (Drug)
Treatment as Usual
Any medication or Rx other than vortixoetine
干预措施: Treatment as Usual (Other)
结局指标
主要结局
change in severity of Cannabis Use Disorder (CUD)
时间窗: 6 months
Change in severity of the cannabis use disorder for the 2 arms as defined by DSM-5
次要结局
- prevalence of Cannabis induced mood disorder(6 months)
- Change in Hamilton anxiety (HAM-A) rating scale(6 months)
- Change in Hamilton depression (HAM-D) rating scale(6 months)
- Change in cognitive outcome(6 months)
研究者
Dr. Albert Kar-Kin Chung
Clinical Assistant Professor
The University of Hong Kong