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Substance Misuse To Psychosis for Stimulants

NCT ID: NCT03485417

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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stimulant psychosis schizophrenia dependence pharmacotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomised single-blinded
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
treatment group randomised to each participant is masked to the outcome assessors

Study Groups

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Aripiprazole Arm

Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

for oral or depot preparation

Paliperidone Arm

Paliperidone (oral or depot) Oral: 3-12mg Depot: Intramuscularly; a) sustenna 50-150mg every four weekly, or b) trinza 273-819mg every 12 weekly

Group Type ACTIVE_COMPARATOR

Paliperidone

Intervention Type DRUG

for oral or depot

Treatment as Usual Arm

Treatment as Usual arm

Group Type OTHER

Treatment as Usual

Intervention Type OTHER

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

Interventions

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Aripiprazole

for oral or depot preparation

Intervention Type DRUG

Paliperidone

for oral or depot

Intervention Type DRUG

Treatment as Usual

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

North District Hospital

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Albert Kar-Kin Chung

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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albert KK Chung, Dr

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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SToP-S

Identifier Type: -

Identifier Source: org_study_id