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

NCT02541513 | Unknown Phase 3

• 1 other identifier: 00004494a
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

paliparidone; amphetamine type stimulant dependence

Outcome Measures

Primary Outcomes (1)

• Reduction in illicit ATS use

  This will be measured from baseline over time during treatment, based on urine toxicology testing and self-report

  18 weeks

Secondary Outcomes (2)

• Reductions in sexual and drug-related HIV risk behaviors

  18 weeks

• Measure improvements in neuropsychological functioning,

  18 weeks

Study Arms (1)

paliparidone

EXPERIMENTAL

All patients will begin receiving oral paliperidone 3 mg daily for 3 days followed by an injection of Paliperidone 150 mg injection on Day 8

Drug: paliparidone

Interventions

paliparidone DRUG

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.

Also known as: invega

paliparidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet DSM-IV criteria for both opioid and ATS dependence, as assessed by the Structured Clinical Interview for DSM (SCID)
• Active COATS dependence as documented by ATS and opioid-positive urine tests and a report of at least 2 or more days per week of ATS use over the past month.
• Age 18 - 65 years old

You may not qualify if:

• Liver enzymes greater than 3 times the upper limit of normal or evidence of liver failure or acute hepatitis.
• Having serious medical or psychiatric illnesses: (including current psychotic disorder, major depression, suicidal or homicidal ideations) or taking medications to treat depression or psychosis.
• Refused informed consent or inability to understand the protocol or assessment questions.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Yale University: collaborator

Study Sites (1)

University Science Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Heroin Dependence; Amphetamine-Related Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Vicknasingam Kasinather, PhD

  University Science Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: September 4, 2015
• Study Start: May 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

MY (1)