跳至主要内容
临床试验/NCT07169409
NCT07169409招募中1 期

Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings

Boulder Care1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年6月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Intervention Acceptability, Appropriateness, Feasibility

研究概览

简要总结

Our primary objective is to evaluate the ability of Boulder Care's telehealth-platform to create the necessary paradigmatic shift in Opioid Use Disorder (OUD) treatment to reach vulnerable populations, with targets that support both equitable and culturally-specific OUD treatment as well as business profitability.

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

  • •History of Opioid Use Disorder (OUD)
  • •Starting OUD treatment with buprenorphine, or within 45 days of starting or restarting this medication
  • •Speak and understand English

排除标准

  • •History of allergic reaction to buprenorphine
  • •Plans to move out of a Boulder Care-affiliated state site in the next 12 months (precluding continuation of care)
  • •Untreated mental or medical health conditions that, in the opinion of the participant, would preclude study participation

研究组 & 干预措施

Receiving Intervention

Experimental

干预措施: Telemedicine Buprenorphine Treatment (Drug)

结局指标

主要结局

Intervention Acceptability, Appropriateness, Feasibility

时间窗: 48 weeks

To measure the participant intervention experience, the study team will utilize qualitative interview data with study participants. These data will be organized into the implementation science categories: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). The study team will determine whether each participant found the intervention to be feasible, acceptable, and/or appropriate. These findings will then be aggregated to better understand how participants experience the implementation of a telemedicine Opioid Use Disorder treatment organization, and will inform a future scaled-up implementation.

次要结局

  • CDC's Health-Related Quality of Life - 4 (CDC HRQOL-4, also called the "Healthy Days Measures")(48 weeks)
  • Brief Addiction Monitor(48 weeks)
  • Visual Analogue Opioid Craving Scale(48 weeks)

研究者

发起方
Boulder Care
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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