Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis)Phase 2/3NCT03485417
Substance Misuse To Psychosis for Stimulants
A Phase 2/3 study testing Aripiprazole, Paliperidone and Treatment as Usual in people with Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis) and Schizophrenia and Related Disorders, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis), Schizophrenia and Related Disorders, Stimulant Dependence
- What is being tested?
- Aripiprazole, Paliperidone and Treatment as Usual
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2019to 31 May 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study
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.
- Conditions
- Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis), Schizophrenia and Related Disorders, Stimulant Dependence, Stimulant Abuse, Pharmacotherapy
- Being tested
- Aripiprazole, Paliperidone, Treatment as Usual
- Keywords
- stimulant, psychosis, schizophrenia, dependence, pharmacotherapy
- Medical subject headings
- Disease, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
for oral or depot preparation
PaliperidoneDrug
for oral or depot
Treatment as UsualOther
to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole Arm | Active comparator | Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly Receives: Drug: Aripiprazole |
| Paliperidone Arm | Active comparator | Paliperidone (oral or depot) Oral: 3-12mg Depot: Intramuscularly; a) sustenna 50-150mg every four weekly, or b) trinza 273-819mg every 12 weekly Receives: Drug: Paliperidone |
| Treatment as Usual Arm | Other | Treatment as Usual arm Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy on psychosis management as measured by the Clinical Global Impression
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).
Measured: at 12th and at 24th months
Secondary outcomes (5)
transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5
The rate of transition from substance induced psychosis To schizophrenia in all 3 different arms
Measured: 24 months
Efficacy on psychosis symptom control as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)
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.
Measured: at 12th and at 24th months
change in stimulant use disorder as defined by DSM-5
The change is severity of the Stimulant Use Disorder in subjects in the 3 different arms by DSM-5 criteria
Measured: At 12th month and at 24th month
Montreal Cognitive Assessment (MoCA)
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.
Measured: At 12th month and at 24th month
Addiction Severity Index (ASL)-lite
Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms
Measured: At 12th and 24th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Jun 2019
- Primary completion31 May 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomised single-blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, North District Hospital
- Responsible party
- Principal investigator, Dr. Albert Kar-Kin Chung, The University of Hong Kong
- Investigators
- albert KK Chung, Dr, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485417
- Sponsor's protocol ID
- SToP-S
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2018
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chung AKK, Tang SW, Tse CY, Law JKC, Lee CK, Leung W, Dong YD, Chan F. Comparative efficacy of aripiprazole and paliperidone to treatment-as-usual in managing stimulant-induced psychosis: a 24-month randomized controlled trial. Front Pharmacol. 2026 Aug 12;17:1892182. doi: 10.3389/fphar.2026.1892182. eCollection 2026.
PubMed 42656845
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study
- ClinicalTrials.gov ID
- NCT03485417
- Acronym / sponsor ID
- SToP-S
- Conditions
- Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis), Schizophrenia and Related Disorders, Stimulant Dependence, Stimulant Abuse, Pharmacotherapy
- Keywords
- stimulant, psychosis, schizophrenia, dependence, pharmacotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, North District Hospital
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- prospective randomised single-blinded
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole Arm | Active comparator | Drug: AripiprazoleAripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly |
| Paliperidone Arm | Active comparator | Drug: PaliperidonePaliperidone (oral or depot) Oral: 3-12mg Depot: Intramuscularly; a) sustenna 50-150mg every four weekly, or b) trinza 273-819mg every 12 weekly |
| Treatment as Usual Arm | Other | Other: Treatment as UsualTreatment as Usual arm |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazolefor oral or depot preparation | Drug | Aripiprazole Arm |
| Paliperidonefor oral or depot | Drug | Paliperidone Arm |
| Treatment as Usualto be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone | Other | Treatment as Usual Arm |
Primary outcome
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).
5 secondary outcomes
transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5
Time frame: 24 months
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
change in stimulant use disorder as defined by DSM-5
Time frame: At 12th month and at 24th month
Montreal Cognitive Assessment (MoCA)
Time frame: At 12th month and at 24th month
Addiction Severity Index (ASL)-lite
Time frame: At 12th and 24th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42656845Chung AKK, Tang SW, Tse CY, Law JKC, Lee CK, Leung W, Dong YD, Chan F. Comparative efficacy of aripiprazole and paliperidone to treatment-as-usual in managing stimulant-induced psychosis: a 24-month randomized controlled trial. Front Pharmacol. 2026 Aug 12;17:1892182. doi: 10.3389/fphar.2026.1892182. eCollection 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
albert KK Chung, Dr principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aripiprazole, Paliperidone and Treatment as Usual in people with Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis) and Schizophrenia and Related Disorders, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy on psychosis management as measured by the Clinical Global Impression (time frame: at 12th and at 24th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.