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

• Status: Unknown status
• Trial end date: 2017-01-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: Universiti Sains Malaysia; University of Science Malaysia
• Collaborator: Yale University
• Treatments: Amphetamine; Paliperidone Palmitate