Substance Misuse To Psychosis for Stimulants

The University of Hong Kong (Other)
Overall Status
Recruiting ID
Queen Mary Hospital, Hong Kong (Other), North District Hospital (Other)

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Anticipated Enrollment :
240 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective randomised single-blindedprospective randomised single-blinded
Single (Outcomes Assessor)
Masking Description:
treatment group randomised to each participant is masked to the outcome assessors
Primary Purpose:
Official Title:
Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Aripiprazole Arm

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

Drug: Aripiprazole
for oral or depot preparation

Active Comparator: 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

Drug: Paliperidone
for oral or depot

Other: Treatment as Usual Arm

Treatment as Usual arm

Other: Treatment as Usual
to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone

Outcome Measures

Primary Outcome Measures

  1. Relative risk of psychosis relapse [36 months]

    The risk of relapse (rate and relative risk) for subjects receiving the active treatments with paliperidone and aripiprazole as compared to treatment as usual

Secondary Outcome Measures

  1. transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5 [36 months]

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

  2. change in stimulant use disorder as defined by DSM-5 [At 12th month and at 36th month]

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

  3. Montreal Cognitive Assessment (MoCA) [At 12th month and at 36th month]

    Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms

  4. Addiction Severity Index (ASL)-lite [At 12th and 36th months]

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

Eligibility Criteria


Ages Eligible for Study:
16 Years to 50 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong 000000

Sponsors and Collaborators

  • The University of Hong Kong
  • Queen Mary Hospital, Hong Kong
  • North District Hospital


  • Principal Investigator: albert KK Chung, Dr, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong Identifier:
Other Study ID Numbers:
  • SToP-S
First Posted:
Apr 2, 2018
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Keywords provided by Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021