Clinical trial NCT03485417: 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
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis)
Schizophrenia and Related Disorders
Stimulant Dependence
Stimulant Abuse
Pharmacotherapy
Keywords: stimulant
psychosis
schizophrenia
dependence
pharmacotherapy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: North District Hospital
First posted: 2018-04-02
Enrollment: 240
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomised single-blinded
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Relative risk of psychosis relapse
timeFrame: 36 months
Secondary outcomes:
measure: transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5
timeFrame: 36 months
measure: change in stimulant use disorder as defined by DSM-5
timeFrame: At 12th month and at 36th month
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At 12th month and at 36th month
measure: Addiction Severity Index (ASL)-lite
timeFrame: At 12th and 36th months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: albert KK Chung, Dr
role: PRINCIPAL_INVESTIGATOR
References: