Substance Misuse To Psychosis for Stimulants

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: albert KK Chung, Dr; Phone Number: +85222553060; Email: chungkka@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Recruiting
    • Queen Mary Hospital
    • Contact: Albert KK Chung; Phone Number: 2255 3067; Email: chungkka@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: North District Hospital; Queen Mary Hospital, Hong Kong
• Investigators: Principal Investigator: albert KK Chung, Dr, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 25, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pharmacotherapy; schizophrenia; psychosis; stimulant; dependence
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Shared Paranoid Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Paliperidone Palmitate
• Other Study ID Numbers: SToP-S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes