Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in a randomized trial
- •Able to complete study instruments and interviews
排除标准
- •Less than 18 years of age
- •Pregnant or planning to be pregnant
- •Currently involved in the criminal justice system
- •Serious mental health problems
- •Treated with buprenorphine
- •Please note: The enrollment target (2.5 randomizations per week over 50 weeks) includes oversampling women and under-represented racial/ethnicity groups (i.e., at least 10 or more individuals per group who identify as Black, Hispanic, and American Indian/Alaskan Native).
结局指标
主要结局
Retention
时间窗: 24 weeks
Length of time the patient remains in treatment after study enrollment
Take homes received over time
时间窗: 24 weeks
The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization
次要结局
- Urine toxicology(24 weeks)
- Opioid cravings(24 weeks)
- Health-related quality of life(24 weeks)
- Opioid withdrawal severity(24 weeks)
- Drug Abuse Treatment Costs Analysis(24 weeks)