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Planned trial compares injectable antipsychotics to usual care for psychosis with stimulant use

Planned trial compares injectable antipsychotics to usual care for psychosis with stimulant use
Photo by Navy Medicine / Unsplash
Key Takeaway
Note: This is a trial record without results; await published data.

This clinical trial record describes a planned phase 2/3 interventional study. The study aims to enroll 165 individuals in Hong Kong with substance use disorders and psychosis, including stimulant-induced psychotic disorder, schizophrenia-related disorders, and stimulant dependence or abuse. The intervention compares long-acting injectable formulations of aripiprazole and paliperidone against treatment as usual. The primary outcome is efficacy on psychosis management measured by the Clinical Global Impression scale.

No results are reported in this trial record. The record provides only the study rationale and design, with no data on efficacy, safety, or tolerability outcomes. Adverse events, serious adverse events, discontinuations, and tolerability are all listed as not reported.

Key limitations include the absence of any outcome data and the fact this is a protocol description rather than a results publication. The study is listed as completed as of May 2024, but no findings are presented here. The University of Hong Kong is listed as the lead sponsor.

Practice relevance cannot be assessed without results. This record serves only to document a planned investigation. Clinicians should await peer-reviewed publication of actual trial outcomes before considering any implications for practice.

Study Details

Study typePhase3
Sample sizen = 165
EvidenceLevel 2
Follow-up60.0 mo
PublishedMar 2026
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2/PHASE3 Condition(s): Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis), Schizophrenia and Related Disorders, Stimulant Dependence, Stimulant Abuse, Pharmacotherapy Intervention(s): Aripiprazole (DRUG), Paliperidone (DRUG), Treatment as Usual (OTHER) 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. Primary Outcome(s): Efficacy on psychosis management as measured by the Clinical Global Impression Enrollment: 165 (ACTUAL) Lead Sponsor: The University of Hong Kong Start: 2019-06-01 | Primary Completion: 2024-05-31
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