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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03485417
Other study ID # SToP-S
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 1, 2019
Est. completion date May 31, 2025

Study information

Verified date July 2023
Source The University of Hong Kong
Contact albert KK Chung, Dr
Phone +85222553060
Email chungkka@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date May 31, 2025
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Aripiprazole
for oral or depot preparation
Paliperidone
for oral or depot
Other:
Treatment as Usual
to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone

Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
The University of Hong Kong North District Hospital, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relative risk of psychosis relapse The risk of relapse (rate and relative risk) for subjects receiving the active treatments with paliperidone and aripiprazole as compared to treatment as usual 36 months
Secondary 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 36 months
Secondary 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 36th month
Secondary Montreal Cognitive Assessment (MoCA) Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms At 12th month and at 36th month
Secondary Addiction Severity Index (ASL)-lite Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms At 12th and 36th months
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