Substance Misuse To Psychosis for Stimulants

Phase

2/3

Condition

Stimulant Use Disorder

Psychosis

Mood Disorders

Treatment

Aripiprazole

Paliperidone

Treatment as Usual

Clinical Study ID

NCT03485417

SToP-S

Ages 16-50
All Genders

Study 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

Inclusion Criteria:

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

Exclusion

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 majordepressive disorder with psychotic features
Had been taking any maintenance dose of oral antipsychotics continuously ≥12 weeksAND 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 oruntreated cardiac disorder
Had mild to severe renal impairment with Glomerular Filtration Rate <80 mililitre /min

Study Design