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| Name | Class |
|---|---|
| Queen Mary Hospital, Hong Kong | OTHER |
| North District Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole Arm | Active Comparator | Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly |
|
| Paliperidone Arm | Active Comparator | Paliperidone (oral or depot) Oral: 3-12mg Depot: Intramuscularly; a) sustenna 50-150mg every four weekly, or b) trinza 273-819mg every 12 weekly |
|
| Treatment as Usual Arm | Other | Treatment as Usual arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | for oral or depot preparation |
| |
| Paliperidone |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at 12th and at 24th months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Efficacy on psychosis symptom control as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24) |
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Inclusion Criteria:
• Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| albert KK Chung, Dr | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | 000000 | Hong Kong |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D000068882 | Paliperidone Palmitate |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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prospective randomised single-blinded
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treatment group randomised to each participant is masked to the outcome assessors
| Drug |
for oral or depot |
|
| Treatment as Usual | Other | to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone |
|
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. |
| 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 | 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. | 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 | At 12th and 24th months |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D011743 | Pyrimidines |