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Substance Misuse To Psychosis for Stimulants

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Aripiprazole
Paliperidone
Treatment as Usual
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis) focused on measuring stimulant, psychosis, schizophrenia, dependence, pharmacotherapy

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Aripiprazole Arm

Paliperidone Arm

Treatment as Usual Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Montreal Cognitive Assessment (MoCA)
Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms
Addiction Severity Index (ASL)-lite
Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms

Full Information

First Posted
March 14, 2018
Last Updated
July 2, 2023
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, North District Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03485417
Brief Title
Substance Misuse To Psychosis for Stimulants
Official Title
Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, North District Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis), Schizophrenia and Related Disorders, Stimulant Dependence, Stimulant Abuse, Pharmacotherapy
Keywords
stimulant, psychosis, schizophrenia, dependence, pharmacotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
prospective randomised single-blinded
Masking
Outcomes Assessor
Masking Description
treatment group randomised to each participant is masked to the outcome assessors
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole Arm
Arm Type
Active Comparator
Arm Description
Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly
Arm Title
Paliperidone Arm
Arm Type
Active Comparator
Arm Description
Paliperidone (oral or depot) Oral: 3-12mg Depot: Intramuscularly; a) sustenna 50-150mg every four weekly, or b) trinza 273-819mg every 12 weekly
Arm Title
Treatment as Usual Arm
Arm Type
Other
Arm Description
Treatment as Usual arm
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
for oral or depot preparation
Intervention Type
Drug
Intervention Name(s)
Paliperidone
Intervention Description
for oral or depot
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone
Primary Outcome Measure Information:
Title
Relative risk of psychosis relapse
Description
The risk of relapse (rate and relative risk) for subjects receiving the active treatments with paliperidone and aripiprazole as compared to treatment as usual
Time Frame
36 months
Secondary Outcome Measure Information:
Title
transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5
Description
The rate of transition from substance induced psychosis To schizophrenia in all 3 different arms
Time Frame
36 months
Title
change in stimulant use disorder as defined by DSM-5
Description
The change is severity of the Stimulant Use Disorder in subjects in the 3 different arms by DSM-5 criteria
Time Frame
At 12th month and at 36th month
Title
Montreal Cognitive Assessment (MoCA)
Description
Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms
Time Frame
At 12th month and at 36th month
Title
Addiction Severity Index (ASL)-lite
Description
Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms
Time Frame
At 12th and 36th months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
albert KK Chung, Dr
Phone
+85222553060
Email
chungkka@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
albert KK Chung, Dr
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert KK Chung
Phone
2255 3067
Email
chungkka@hku.hk

12. IPD Sharing Statement

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Substance Misuse To Psychosis for Stimulants

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