NCT02541513 is a Phase 3 clinical trial of paliparidone in Heroin Dependence, sponsored by Universiti Sains Malaysia.

Who is sponsoring NCT02541513?

NCT02541513 is sponsored by Universiti Sains Malaysia.

What drugs are being tested in NCT02541513?

Interventions in NCT02541513: paliparidone.

What condition does NCT02541513 study?

NCT02541513 studies Heroin Dependence, Amphetamine Dependence.

Is NCT02541513 still recruiting?

NCT02541513 is currently status unknown. Last updated 1 September 2015.

Last reviewed 2015-09-01 · How we verify

NCT02541513

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-label Study of Oral Paliparidone for the Treatment of Patients With Co-occurring Opioid and Amphetamine-type Stimulant Dependence

Status unknown Phase 3 Last updated 1 September 2015

What this trial tests

Phase 3 trial testing paliparidone in Heroin Dependence in 40 participants. Status unknown.

Timeline

1 May 2013

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Universiti Sains Malaysia
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 May 2013
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	1 location across Malaysia

Drugs / interventions tested

paliparidone — full drug profile →

Conditions studied

Heroin Dependence — all drugs for Heroin Dependence →
Amphetamine Dependence — all drugs for Amphetamine Dependence →

Sponsor

Universiti Sains Malaysia — full company profile →

Who can join

Adults 18 to 65, male only, with Heroin Dependence or Amphetamine Dependence. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Reduction in illicit ATS use
Time frame: 18 weeks
This will be measured from baseline over time during treatment, based on urine toxicology testing and self-report

Sponsor's own description

The proposed study will evaluate the tolerability, acceptability and potential efficacy of paliparidone for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS) dependence. In the proposed clinical trial, all patients will first discontinue illicit opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the inpatient ward at the department of psychiatry before beginning to receive paliparidone. Tolerability and acceptability will be evaluated by assessing the rates of patient retention during treatment, patient satisfaction with treatment and adverse effects during treatment. The potential efficacy of paliparidone will be evaluated with regard to the primary outcome measure: reductions in illicit ATS use, based on urine toxicology testing and self-report. Secondary outcome measures include treatment retention, reduction in HIV risk behaviors and improvements in functional status.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Subregion-specific transcriptomic profiling of rat brain reveals sex-distinct gene expression impacted by adolescent stress.
Krolick KN, Cao J, Gulla EM, Bhardwaj M, et al · · 2024 · cited 4× · PMID 38977070 · DOI 10.1016/j.neuroscience.2024.07.002

Verify or expand the search:

Other Universiti Sains Malaysia trials

Trials by the same sponsor.

NCT07397104 — Validity of a Self-reported Questionnaire for Periodontal Status in a Saudi Population · not yet recruiting
NCT07279324 — Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease · NA · not yet recruiting
NCT07338045 — The Effects of Eight-Week Baduanjin Exercise on Chronic Low Back Pain and Disability Among Office Workers. · NA · not yet recruiting
NCT07410351 — Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi · not yet recruiting
NCT07448909 — Cognitive-Frailty Gait Biomechanics for Early Dementia Detection · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02541513 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universiti Sains Malaysia
Last refreshed: 1 September 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02541513.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing