A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- PEAR-002B User Satisfaction Surveys
研究概览
简要总结
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
详细描述
The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O.
This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process.
This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent prior to any study specific assessments being performed
- •Male or female ≥18 years of age, inclusive
- •English proficiency to meaningfully participate in consent process, assessment and intervention
- •Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use)
- •Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment
- •Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet)
- •Interested in testing or using PEAR-002b
- •No prior history of reSET-O use
- •Has not participated in any other investigational drug trials within the past 30 days (or within 5 half-lives of study drug, whichever is longer) of enrollment
- •Is considered appropriate for participation by their clinician
排除标准
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy
- •DSM-5 diagnosis of OUD and already on buprenorphine
- •Planning to move out of the geographic area within 2 months
- •Unable to use English to participate in the consent process, the interventions, or assessments
- •Inability to comply with study procedures, due to severe medical conditions or otherwise
- •Currently receiving inpatient treatment for OUD
- •Women who are pregnant
结局指标
主要结局
PEAR-002B User Satisfaction Surveys
时间窗: Week 1
Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints
PEAR-002B Qualitative User Experience Interviews
时间窗: Week 1
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Buprenorphine Initiation Success
时间窗: Week 1
Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit
Medication Adherence Rates
时间窗: From Week 1 to Week 4
Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine
次要结局
- PEAR-002B Engagement Data(From Baseline to Week 1)
- reSET-O Qualitative User Experience Interviews(Week 4)
- reSET-O User Satisfaction Surveys(Week 4)