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Substance Misuse To Psychosis for Stimulants

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ClinicalTrials.gov Identifier: NCT03485417
Recruitment Status : Not yet recruiting
First Posted : April 2, 2018
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
North District Hospital
Information provided by (Responsible Party):
Dr. Albert Kar-Kin Chung, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective 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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Relative risk of psychosis relapse [ Time Frame: 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 :
  1. transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5 [ Time Frame: 36 months ]
    The rate of transition from substance induced psychosis To schizophrenia in all 3 different arms

  2. change in stimulant use disorder as defined by DSM-5 [ Time Frame: 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

  3. Montreal Cognitive Assessment (MoCA) [ Time Frame: At 12th month and at 36th month ]
    Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms

  4. Addiction Severity Index (ASL)-lite [ Time Frame: At 12th and 36th months ]
    Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485417


Contacts
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Contact: albert KK Chung, Dr +85222553060 chungkka@hku.hk

Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, 000000
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
North District Hospital
Investigators
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Principal Investigator: albert KK Chung, Dr The University of Hong Kong

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Responsible Party: Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03485417     History of Changes
Other Study ID Numbers: SToP-S
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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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

Keywords provided by Dr. Albert Kar-Kin Chung, The University of Hong Kong:
stimulant
psychosis
schizophrenia
dependence
pharmacotherapy

Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Shared Paranoid Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Aripiprazole
Paliperidone Palmitate
Central Nervous System Stimulants
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists