Treatment for stimulant misuse and psychosis
Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study
This study is testing whether long-acting injections of antipsychotic medications can help people in Hong Kong who misuse stimulants and have psychosis feel better and reduce their symptoms.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03485417 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of long-acting injectable antipsychotics, specifically aripiprazole and paliperidone, in treating individuals with stimulant use disorder who also experience psychosis. It aims to provide an evidence-based pharmacotherapy intervention to prevent the progression of substance dependence and related psychiatric disorders. The study will focus on patients in Hong Kong who have a history of stimulant misuse and psychotic symptoms, utilizing a combination of medication and standard treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with stimulant use disorder who exhibit psychotic symptoms.
Not a fit: Patients with a history of schizophrenia or other substance-induced psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve treatment adherence and outcomes for patients with stimulant-induced psychosis.
How similar studies have performed: Other studies have shown promise in using long-acting injectable antipsychotics for similar patient populations, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: albert KK Chung, Dr — The University of Hong Kong
- Study coordinator: albert KK Chung, Dr
- Email: chungkka@hku.hk
- Phone: +85222553060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.