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NCT03485417CompletedPhase 2/3

Substance Misuse To Psychosis for Stimulants

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
165 (actual)
First submitted
14 Mar 2018
Start date
1 Jun 2019
Primary completion date
31 May 2024
Lead sponsor
The University of Hong Kong
NCT number
NCT03485417

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 165
  • From 1 Jun 2019 to the primary completion date, 31 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Had been receiving any maintenance dose of long-acting injectable (LAI/depot) antipsychotics continuously ≥4 month AND with psychotic symptoms in remission

Other illness

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

Lab values

  • Had history of prolonged corrected QT interval (QTc) ≥500ms and/or known unstable or untreated cardiac disorder

Age

  • Age \<16 years old

Other

  • 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 taking any maintenance dose of oral antipsychotics continuously ≥12 weeks AND with psychotic symptoms in remission
  • Pregnant
  • Mother currently breast-feeding

Who the study is looking for

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

Age in the registry: 16 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queen Mary Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.