Substance Misuse To Psychosis for Stimulants

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pharmacotherapy; Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis); Stimulant Abuse; Schizophrenia and Related Disorders; Stimulant Dependence

Treatments: Drug: Aripiprazole; Drug: Paliperidone; Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03485417

SToP-S

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 3 patient groups

Aripiprazole Arm

Active Comparator group

Description:

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

Treatment:

Drug: Aripiprazole

Paliperidone Arm

Active Comparator group

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

Treatment:

Drug: Paliperidone

Treatment as Usual Arm

Other group

Description:

Treatment as Usual arm

Treatment:

Other: Treatment as Usual