Substance Misuse To Psychosis for Stimulants

Study Overview
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Brief Summary
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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.

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

Conditions
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Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis), Schizophrenia and Related Disorders, Stimulant Dependence, Stimulant Abuse, Pharmacotherapy

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Paliperidone
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomised single-blinded
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aripiprazole Arm<br>Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly | Drug: Aripiprazole<br>* for oral or depot preparation<br>|
| Active Comparator: Paliperidone Arm<br>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<br>* for oral or depot<br>|
| Other: Treatment as Usual Arm<br>Treatment as Usual arm | Other: Treatment as Usual<br>* to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk of psychosis relapse | The risk of relapse (rate and relative risk) for subjects receiving the active treatments with paliperidone and aripiprazole as compared to treatment as usual | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 36 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 | At 12th month and at 36th month | 
| Montreal Cognitive Assessment (MoCA) | Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms | At 12th month and at 36th month | 
| Addiction Severity Index (ASL)-lite | Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms | At 12th and 36th months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stimulant, psychosis, schizophrenia, dependence, pharmacotherapy