Clinical Trial: Mirtazapine as a Treatment for Co-Occurring Opioid and ATS Dependence in Malaysia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mirtazapine as a Treatment for Co-Occurring Opioid and Amphetamine Type Stimulant Dependence (COATS) in Malaysia

Brief Summary: The purpose of this study is to evaluate tolerability, acceptability and potential efficacy of 4 months of maintenance treatment with Mirtazapine as compared to placebo for patients with co-occurring amphetamine-type stimulant and opioid dependence (COATS) receiving buprenorphine maintenance treatment (BMT) in Kota Bharu.

Detailed Summary:

Amphetamine type stimulant (ATS) and opioid abuse, dependence and injection drug use (IDU) are major public health problem in Malaysia and nearby countries (including China, Indonesia, Thailand, Vietnam, Myamar, and Cambodia) and are the major drivers of the HIV/AIDS epidemic in these countries.1 Opioids (predominantly heroin, morphine, or, to a lesser extent, opium) are the primary drugs of abuse for most drug users in Malaysia and the region. There are more than 300,000 registered drug users in Malaysia (estimated >500,000 total); most are opioid dependent and current IDUs; 25-30% of IDUs are infected with HIV; and IDU accounts for 70% of HIV infections in Malaysia (91,360 registered HIV+ between 1986 and 2010).6 Over the past decade, ATS has also emerged as an additional major drug problem. Globally, ATS is now the second most commonly used illicit drug type (after marijuana) and is more widely used than heroin.1-6, 2 ATS abuse is especially prevalent and problematic in the Asian region, where ATS production, use, drug seizures, demand for treatment, and medical consequences have continued to increase through the most recent 2011 report. Laboratories producing ATS have been identified in more than half of the countries in the region; large scale laboratories capable of industrial-scale manufacture have been found in Malaysia, China, and Indonesia. Injection of methamphetamine has been reported in Malaysia, Indonesia, Thailand, and Singapore. Data from our recently completed studies and others document a rapid rise in the prevalence of ATS use among opioid IDUs over the past decade; in the most recent survey of out-of-treatment heroin IDUs in cities across Malaysia, more than 60% report current ATS use, and 29% inject ATS.

ATS use is associated with increased behavioral risks of HIV transmission (even in already at high risk opioid IDUs), In our earlier studies condu
Sponsor: University of Science Malaysia

Current Primary Outcome: Reduction of 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 HIV risk behaviour iii) Improvement of social functioning [ Time Frame: 18 weeks ]
    Measured by repeated assessments of sexual and HIV risk behaviours
  • 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: May 2017
Last Updated: September 1, 2015
Last Verified: September 2015