Substance Misuse To Psychosis for Stimulants

Phase 2

Recruiting

• Conditions: Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis); Schizophrenia and Related Disorders; Stimulant Dependence; Stimulant Abuse; Pharmacotherapy
• Interventions: Drug: Paliperidone; Other: Treatment as Usual; Drug: Aripiprazole

• Registration Number: NCT03485417
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-25
• Study First Posted: 2018-04-02
• Study Start: 2019-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-02
• Last Update Posted: 2023-07-05
• Primary Completion: 2024-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paliperidone Arm	Paliperidone	Paliperidone (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	Treatment as Usual	Treatment as Usual arm
Aripiprazole Arm	Aripiprazole	Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong