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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Malaysia has been struggling in fighting drug addiction in the country (NADI, 2005). Opioids predominantly heroin and morphine and ATS (Chawarski et al, 2006). dependence are the primary drugs of abuse for most drug users in Malaysia There are more than 300,000 registered drug users in Malaysia, most are opioid dependent and current intravenous drug users (IVDU). Drug abuse comes together with other medical and social problems, as 25-30% of IVDU are infected with HIV; and IVDU accounts for 70% of HIV infections in Malaysia. There are more than 90, 000 registered HIV positives between 1986 and 2010. (National Anti-Drug Agency of Malaysia, 2010).

Over the past decade, amphetamine-type stimulant (ATS) has also emerged as a major drug problem. Globally, ATS is now the second most commonly used illicit drug type and is more widely used than heroin. ATS abuse is especially prevalent and problematic in the Asian region, where ATS production, use, drug seizures, and demand for treatment have continued to increase. Injection of methamphetamine has been reported in Malaysia (Chawarski et al, 2006) and other south-east Asian countries (McKetin, 2008). In the most recent survey of out-of-treatment heroin IVDU in cities across Malaysia, more than 60% report current ATS use, and 29% inject ATS (Chawarski et al, 2012).

ATS use is associated with increased HIV transmission behavioral risks. The connection of heroin, methamphetamine and HIV in Malaysia is well documented (Chawarski et al, 2006). Increased needle sharing and risky sexual behaviors lead to increased prevalence of HIV infection. ATS use exacerbates HIV transmission risk through a number of mechanisms: ATS users report engaging in more frequent and more risky sexual behaviors while using ATS and in more frequent needle sharing. ATS is also associated with impairments of mood a
Sponsor: University of Science Malaysia

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reductions in sexual and drug-related HIV risk behaviors [ Time Frame: 18 weeks ]
    Measured by monthly self-report assessments using a questionnaire
  • Measure improvements in neuropsychological functioning, [ Time Frame: 18 weeks ]
    Measured by repeated assessments of neuropsychological functioning


Original Secondary Outcome: Same as current

Information By: University of Science Malaysia

Dates:
Date Received: June 29, 2015
Date Started: May 2013
Date Completion: January 2017
Last Updated: September 1, 2015
Last Verified: September 2015