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Completed

NCT Number: NCT03485417

Substance Misuse To Psychosis for Stimulants

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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Key information

Conditions

Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis) Disease Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacotherapy Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia and Related Disorders Stimulant Abuse Stimulant Dependence

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Queen Mary Hospital

Hong Kong, 000000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole

Drug

for oral or depot preparation

Paliperidone

Drug

for oral or depot

Treatment as Usual

Other

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

Primary outcomes

  1. Efficacy on psychosis management as measured by the Clinical Global Impression

    Time frame: at 12th and at 24th months

    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).

Secondary outcomes

  1. transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5

    Time frame: 24 months

    The rate of transition from substance induced psychosis To schizophrenia in all 3 different arms

  2. Efficacy on psychosis symptom control as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)

    Time frame: at 12th and at 24th months

    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.

  3. change in stimulant use disorder as defined by DSM-5

    Time frame: At 12th month and at 24th month

    The change is severity of the Stimulant Use Disorder in subjects in the 3 different arms by DSM-5 criteria

  4. Montreal Cognitive Assessment (MoCA)

    Time frame: At 12th month and at 24th month

    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.

  5. Addiction Severity Index (ASL)-lite

    Time frame: At 12th and 24th months

    Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • North District Hospital
  • Queen Mary Hospital, Hong Kong

Registry information

Official study title

Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Apr 2, 2018
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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