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

NCT02541513 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-09-04

No results posted yet for this study

Summary

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.

Conditions

  • Heroin Dependence
  • Amphetamine Dependence

Interventions

DRUG

paliparidone

All patients will begin receiving oral paliperidone 3 mg daily for three days, beginning on Day 5 of the inpatient phase. All patients will receive an injection of Paliperidone 150 mg injection on Day 8 of the inpatient phase. Patients will receive monthly 150 mg injection for the next 3 months.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Vicknasingam Kasinather, PhD · University Science Malaysia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541513 on ClinicalTrials.gov