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
for oral or depot preparation
for oral or depot
to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone
Queen Mary Hospital
Hong Kong, Hong Kong
Efficacy on psychosis management as measured by the Clinical Global Impression
The efficacy for managing stimulant associated psychosis for subjects receiving the active treatments with aripiprazole and paliperidone as compared to treatment-as-usual is measured by the Clinical Global Impression (CGI). The Clinical global impression consists of 3 components: CGI-severity (CGI-S), CGI-Improvement (CGI-I) and CGI-efficacy (CGI-E). CGI-S and CGI-I are both 7-point item, ranging from 0 (normal) to 7 (severely ill) and 0 (very much improved) to 7 (very much worse), respectively. The CGI-efficacy is the composite measured of its therapeutic effect and side effects, with scoring ranging from 1 (marked therapeutic effect) to 16 (unchanged with side effects outweighed therapeutic effects).
Time frame: at 12th and at 24th months
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
Efficacy on psychosis symptom control as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)
The efficacy for controlling symptoms of 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 symptoms.
Time frame: at 12th and at 24th 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
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