Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Efficacy on psychosis as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)
研究概览
简要总结
In Hong Kong, less than 5% of stimulants abusers were reported to misuse these substances via injection. Also, it is well known that patients with co-morbid substance abuse/dependence and psychosis or schizophrenia-related disorders are prone to earlier treatment discontinuation and high oral medication non-adherence, resulting in poorer overall outcomes. With the recent availabilities of the 4-weekly long-acting injectable form of aripiprazole, and the 4-weekly and the 3-monthly long-acting injectable form of paliperidone palmitate, on the background of the surging phenomenon of stimulant misuses in Hong Kong, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with substance use disorders with psychosis 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 group randomised to each participant is masked to the outcome assessors
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
- •Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis
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 (ICD-10 F70-73)
- •Had been diagnosed to have Schizophrenia
- •Had been diagnosed to have other substance-induced psychotic or mood disorder, including alcohol
- •Had been diagnosed to have bipolar disorder viii. Had been diagnosed to have major depressive disorder with psychotic features
- •Had been taking any maintenance dose of oral antipsychotics continuously ≥12 weeks AND with psychotic symptoms in remission
- •Had been receiving any maintenance dose of long-acting injectable (LAI/depot) antipsychotics continuously ≥4 month AND with psychotic symptoms in remission
- •Had known hypersensitivity to risperidone (oral or LAI), paliperidone (oral or LAI), or aripiprazole (oral or LAI)
- •Had known history of tardive dyskinesia
- •Had known history of neuroleptic malignant syndrome
- •Mother currently breast-feeding
- •Had history of prolonged corrected QT interval (QTc) ≥500ms and/or known unstable or untreated cardiac disorder
- •Had mild to severe renal impairment with Glomerular Filtration Rate <80 mililitre /min
研究组 & 干预措施
Aripiprazole Arm
Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly
干预措施: Aripiprazole (Drug)
Paliperidone Arm
Paliperidone (oral or depot) Oral: 3-12mg Depot: Intramuscularly; a) sustenna 50-150mg every four weekly, or b) trinza 273-819mg every 12 weekly
干预措施: Paliperidone (Drug)
Treatment as Usual Arm
Treatment as Usual arm
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Efficacy on psychosis as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)
时间窗: at 12th and at 24th months
The efficacy for controlling stimulant associated psychosis for subjects receiving the active treatments with paliperidone and aripiprazole as compared to treatment as usual is measured by BPRS. The lowest score of BPRS-24 is 24. The lower the score of BPRS refers to better efficacy in controlling psychosis.
次要结局
- transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5(24 months)
- change in stimulant use disorder as defined by DSM-5(At 12th month and at 24th month)
- Montreal Cognitive Assessment (MoCA)(At 12th month and at 24th month)
- Addiction Severity Index (ASL)-lite(At 12th and 24th months)
研究者
Dr. Albert Kar-Kin Chung
Clinical Assistant Professor
The University of Hong Kong