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

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

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

Brief Summary: The proposed study will evaluate the tolerability, acceptability and potential efficacy of minocycline 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 minocycline. 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 minocycline will be evaluated with regard to the primary outcome measure: reductions in ATS use , based on urine toxicology testing and self-report. Secondary outcome measures include retention, reduction in HIV risk behaviors and improvements in functional status.

Detailed Summary:

Additional data available to this project will come from contemporaneous and historical drug treatment clinical trials and treatment programs conducted at HUSM with similar populations of patients and proposed/described as other components of the cluster of research projects described in the overall Research University Team Grant proposal. Comparisons of treatment process and outcome measures collected in this proposed clinical trial with data collected in contemporaneous and historical controls will enhance our ability to evaluate the potential efficacy of minocycline as treatment agent for co-occurring opioid and amphetamine-type stimulant (ATS) dependence. Data from patients receiving other drug treatments at HUSM will be used as reference points to evaluate potential effect sizes of treatment effects associated with minocycline treatment. The preliminary data on treatment retention data, patient satisfaction, potential adverse effects, and efficacy will be used as preliminary/pilot research when designing and applying for funding support for future large scale randomized clinical trials aimed at the development of effective medically based treatments of opiate and ATS abuse or dependence.

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).

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