A Randomized, Controlled, Open-Label, Decentralized Study, to Evaluate Patient Engagement With PEAR-008, a Game-Based Digital Therapeutic for the Treatment of Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Evaluate Participant Engagement Data
研究概览
简要总结
The purpose of this study is to evaluate how patients use and engage with a game-based mobile application that is designed to treat opioid use disorder.
详细描述
This is a randomized, controlled, open-label, decentralized study to evaluate patient engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder.
PEAR-008 is a new version of reSET-O, an FDA-authorized mobile application treatment (available by prescription only) for opioid use disorder. The study will examine if changing the application's delivery format and enhancing clinical content affects how patients use and interact with the intervention.
Prospective participants will complete a short screening assessment and if eligible complete informed consent procedures at the beginning of the Baseline visit. Qualifying participants will attend weekly virtual study visits during the 8-week treatment period.
In addition to weekly assessments, additional assessments will be administered at week 4 and week 8. Participants will be asked to complete a follow-up assessment 4 weeks after completing treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent Outcomes Assessor will conduct data analysis and be blinded to intervention assignments.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide informed consent prior to any study specific assessments being performed
- •Between 18 and 60 years old, inclusively
- •Proficient in English language
- •Within the first 120 days of starting buprenorphine treatment
- •Receiving buprenorphine pharmacotherapy under the care of a licensed healthcare provider and willing to provide the provider or practice name
- •Capable of using common software applications on a mobile device (smartphone)
- •Access to an internet-enabled smartphone for the duration of the study, meeting minimal operations systems (OS) requirements
- •Interest in using a digital therapeutic for Opioid-use Disorder
- •No prior history of reSET-O use
- •Has not participated in user testing of PEAR-008 or any investigational drug trials within the past 30 days of enrollment
排除标准
- •On methadone or naltrexone pharmacotherapy
- •Unable to use English to participate in the consent process, interventions, or assessments
- •Inability to comply with study procedures
结局指标
主要结局
Evaluate Participant Engagement Data
时间窗: From Week 1 to Week 8 (End of Treatment)
Evaluate the number of active sessions per week between PEAR-008 and reSET-O
次要结局
- Evaluate Digital Therapeutic Use Patterns Based on Usage Data(From Week 1 to Week 8 (End of Treatment))
- Evaluate Illicit Drug Abstinence(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up))
- Assess Effect on Anxiety Symptoms(Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up))
- Describe Participant Satisfaction Surveys(Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up))
- Assess Coronavirus Disease (COVID-19) Impact(Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up))
- Evaluate Treatment Retention Based on Drop-Out Rates(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up))
- Describe Participant Satisfaction Interviews(Week 12 (Follow-up))
- Assess Effect on Recovery Capital(Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up))
- Assess Effect on Resilience(Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up))
- Assess Effect on Depressive Symptoms(Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up))
- Assess Coronavirus Disease (COVID-19) Impact on Stress(Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up))