ACTRN12618000942257已完成2 期
Assessing the Safety and Feasibility of Long-Acting Depot of Buprenorphine in Adults Requiring Treatment for Opioid Use Disorder in NSW Custodial Settings
SW Ministry of Health0 个研究点目标入组 129 人开始时间: 2018年6月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adult male and female prisoners (aged 18 years or older) sentenced in full-time custody
- •2. Demonstrating sufficient English language ability and willing to provide written informed consent
- •3. Sentenced for all charges, with at least six months remaining on sentence
- •4. Willing and able to comply with requirements of the study
- •5. Meets the criteria for opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders – 5th Edition (DSM-5) for moderate to severe opioid use disorder
- •6. Appropriate candidate for medically assisted treatment with partial/full opioid agonist treatment as determined by the Principal Investigator
排除标准
- •1. General clinical contraindications for partial/full opioid agonist treatment (see National Guidelines for Medication-Assisted Treatment of Opioid Dependence, 2014)
- •2. Current, severe medical condition (e.g. hepatic failure or respiratory insufficiency) assessed by Principal Investigator
- •3. Any known hypersensitivity to methadone or buprenorphine
- •4. Participants with a serious untreated psychiatric comorbidity at the discretion of the Principal Investigator
- •5. Recent history of suicidal ideation or active suicidal behaviour as based on the Columbia Suicide Severity Rating Scale (C-SSRS) and/or clinical assessment
- •6. Forensic mental health patient not guilty by reason of mental illness
- •7. Clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the patient from safely participating in trial
- •8. History of risk factors of Torsades de Pointes heart arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome) or an electrocardiogram (ECG) demonstrating a clinically significant abnormality, as judged by the Investigator
- •9. Requires chronic use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4) such as some azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. clarithromycin), or protease inhibitors (e.g. ritonavir, indinavir, and saquinavir) or other inducers (e.g. phenobarbital, carbamazepine, phenytoin and rifampicin)
- •10. Benzodiazepine use disorder based on clinical assessment
- •11. Currently breastfeeding or pregnant
- •12. Patients who have had an investigational new drug or device within the last 30 days
- •13. Patient is on his/her parole period (past earliest date of release)
- •14. Patient is enrolled in a residential or intensive treatment program (Intensive Drug Treatment Program, Intensive Sex Offender Treatment Program, Compulsory Drug Treatment Program and Drug Court Program)
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