Substance Misuse To Psychosis for Stimulants

NCT03485417 | Completed Phase 2 FDA Drug

• 1 other identifier: SToP-S
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stimulant; psychosis; schizophrenia; dependence; pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  at 12th and at 24th months

Secondary Outcomes (5)

• transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5

  24 months

• Efficacy on psychosis symptom control as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)

  at 12th and at 24th months

• change in stimulant use disorder as defined by DSM-5

  At 12th month and at 24th month

• Montreal Cognitive Assessment (MoCA)

  At 12th month and at 24th month

• Addiction Severity Index (ASL)-lite

  At 12th and 24th months

Study Arms (3)

Aripiprazole Arm

ACTIVE COMPARATOR

Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly

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

Drug: Paliperidone

Treatment as Usual Arm

OTHER

Treatment as Usual arm

Other: Treatment as Usual

Interventions

Aripiprazole DRUG

for oral or depot preparation

Aripiprazole Arm

Paliperidone DRUG

for oral or depot

Paliperidone Arm

Treatment as Usual OTHER

to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone

Treatment as Usual Arm

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• North District Hospital: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

Disease; Schizophrenia; Psychotic Disorders

Interventions

Aripiprazole; Paliperidone Palmitate; Therapeutics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isoxazoles; Azoles; Pyrimidines

Study Officials

• albert KK Chung, Dr

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: treatment group randomised to each participant is masked to the outcome assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: prospective randomised single-blinded

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 2, 2018
• Study Start: June 1, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

HK (1)