Increasing Retention in Methadone Maintenance Treatment: Feasibility and Preliminary Efficacy of Ketamine for the Treatment of Patients With OUD and Comorbid Depression (OUDCD)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Feasibility: Study Recruitment
研究概览
简要总结
Methadone is a first-line, evidence-based treatment for opioid use disorder (OUD). Unfortunately, retention and adherence in methadone treatment is a major challenge. OUD patients frequently present with co-morbid depression (OUDCD), a risk factor for poor OUD treatment outcomes, overdose, and suicide. The last two decades have seen an exciting and transformational development in the treatment of depression - ketamine. As a safe, rapid-acting anti-depressant deliverable within the context of methadone maintenance treatment, ketamine could feasibly change the landscape of treatment for OUD patients with comorbid depression. This proposal seeks to evaluate implementation outcomes (feasibility and patient acceptance) as well as preliminary efficacy of ketamine on methadone treatment outcomes for OUD patients (n=6) with comorbid depression and depressive symptoms presenting for methadone treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketamine
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
Feasibility: Study Recruitment
时间窗: One year
Feasibility will be assessed via participant recruitment: 50% of eligible patients approached will consent to participation in the pilot.
Feasibility: Study Retention
时间窗: One year
75% of participants will be retained throughout the duration of ketamine infusion procedures
Patient Acceptability: Acceptability of the Intervention Measure (AIM)
时间窗: One month
Acceptance will be assessed via scores on the Acceptability of the Intervention Measure (AIM): Distribution summarized with mean and 95% C.I. Scale values range from 1 to 5 with higher mean values representing greater agreement and/or acceptability.
Patient Acceptability: Engagement
时间窗: One month
Engagement will be assessed via dosing records of observed ketamine administration: distribution of percentage of completed infusions per patient.
次要结局
- Patient Treatment Retention(Three months)
- Changes in Psychiatric Diagnosis of Depression(One month)
- Changes in Depressive Symptoms(One month)
研究者
Annabelle Belcher
Assistant Professor
University of Maryland, Baltimore