Substance Misuse To Psychosis for Stimulants

Last updated: July 4, 2025
Sponsor: The University of Hong Kong
Overall Status: Completed

Phase

2/3

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Substance Abuse

Stimulant Use Disorder

Treatment

Paliperidone

Aripiprazole

Treatment as Usual

Clinical Study ID

NCT03485417
SToP-S
  • Ages 16-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis

Exclusion

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 majordepressive disorder with psychotic features

  • Had been taking any maintenance dose of oral antipsychotics continuously ≥12 weeksAND 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 oruntreated cardiac disorder

  • Had mild to severe renal impairment with Glomerular Filtration Rate <80 mililitre /min

Study Design

Total Participants: 165
Treatment Group(s): 3
Primary Treatment: Paliperidone
Phase: 2/3
Study Start date:
June 01, 2019
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Queen Mary Hospital

    Hong Kong, 000000
    Hong Kong

    Site Not Available

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