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Can Long-Acting injections stop stimulant psychosis from worsening?

NCT ID NCT03485417

Disease control Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two long-acting injectable medications, aripiprazole and paliperidone, in 165 people who use stimulants and have psychosis. The goal was to see if these drugs could better manage psychosis and prevent progression to chronic schizophrenia compared to standard treatment. Participants were randomly assigned to one of the two medications or to usual care, and their symptoms were tracked over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aripiprazole and paliperidone (long-acting injectable forms)
What this could lead to
If successful, this could provide an evidence-based treatment strategy to better manage psychosis in people who use stimulants and reduce the risk of long-term dependence.
What could go wrong
This is a completed Phase 2/3 trial with 165 participants in Hong Kong, so results may not apply to other populations. The medications have side effects, and the study compares them to usual care, which may limit how broadly the findings can be used.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

165 people

The number who actually took part.

Started

Jun 2019

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

amphetamine abuse disease Psychotic Disorders Schizophrenia substance dependence substance-induced psychosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pharmacotherapy Schizophrenia and related disorders Stimulant abuse Stimulant dependence Stimulant use with stimulant-induced psychotic disorder (diagnosis)

Contacts and locations

Locations

  • Queen Mary Hospital

    Hong Kong, 000000, Hong Kong

More trials for these conditions

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