Substance Misuse To Psychosis for Stimulants

Sponsor

The University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT03485417

Collaborator

Queen Mary Hospital, Hong Kong (Other), North District Hospital (Other)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

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.

Condition or Disease	Intervention/Treatment	Phase
Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis) Schizophrenia and Related Disorders Stimulant Dependence Stimulant Abuse Pharmacotherapy	Drug: Aripiprazole Drug: Paliperidone Other: Treatment as Usual	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective randomised single-blindedprospective randomised single-blinded

Masking:

Single (Outcomes Assessor)

Masking Description:

treatment group randomised to each participant is masked to the outcome assessors

Primary Purpose:

Treatment

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

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

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

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
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
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

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

All

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