Substance Misuse To Psychosis for Stimulants

The University of Hong Kong165 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

165

Conditions

Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis)Schizophrenia and Related Disorders Stimulant Dependence

Interventions

AripiprazoleDRUG

for oral or depot preparation

PaliperidoneDRUG

for oral or depot

Treatment as UsualOTHER

to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone

Eligibility

Sex: ALLMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis 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 (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 * Pregnant * 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

Outcomes

Primary Outcomes

Efficacy on psychosis as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)

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.

Time frame: at 12th and at 24th months

Secondary Outcomes

transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5

The rate of transition from substance induced psychosis To schizophrenia in all 3 different arms

Time frame: 24 months

change in stimulant use disorder as defined by DSM-5

The change is severity of the Stimulant Use Disorder in subjects in the 3 different arms by DSM-5 criteria

Time frame: At 12th month and at 24th month

Montreal Cognitive Assessment (MoCA)

Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms. MoCA has the maximum score of 30. A cut-off score of higher than or equal to 26 refers to normal cognition.

Time frame: At 12th month and at 24th month

Addiction Severity Index (ASL)-lite

Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms

Time frame: At 12th and 24th months