An open-label, phase 3 study of the safety of the O’Neil Long Acting Naltrexone Implant treatment for substance dependence

Go Medical Industries Inc0 个研究点目标入组 500 人开始时间: 2009年8月11日最近更新: 2020年1月13日

试验速览

暂无简介。

•1.Primary diagnosis of substance dependence (defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria).
•2.Able and willing to comply with requirements of the protocol.
•3.Able and willing to provide written informed consent.
•4.Willing to undergo standard detoxification (if required) and implant procedure.

•1.Participation in another clinical drug trial during the last 12 weeks.
•2.Women during the lactation period, or pregnant as confirmed by positive urine pregnancy.
•3.Severe psychiatric disease, in the opinion of the investigator, which will interfere with the subject's ability to provide research data and informed consent.
•4.Subjects who, in the opinion of the investigator, are not likely to complete the study for what ever reason.
•5.Subjects with any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data and full physical examination. Stable medical conditions unlikely to affect patient safety or the outcome of the investigation may be acceptable if agreed by the study monitor appointed by the sponsor.
•6.Patient lives outside the Perth metropolitan area or cannot provide sufficient contact details to make follow-up over a sustained period successful.
•7.Medical condition which requires narcotic treatment for control of pain.

发起方

Go Medical Industries Inc