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临床试验/NCT04239235
NCT04239235已完成不适用

Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care

Stanford University12 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2021年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
439
试验地点
12
主要终点
Patient buprenorphine retention

研究概览

简要总结

INtegrated Support Persons Into Recovery (INSPIRE) is a 4-year research project that tests whether integrating a patient's support person into a patient's treatment with Buprenorphine/Naloxone can improve outcomes. The study will examine whether a counseling program called CRAFT for a support person, such as a family member, spouse or friend, can improve patient outcomes.

详细描述

Opioid use disorders (OUDs) have reached an all-time high and have devastating effects on the individual, family, and community. While medication treatment for OUD saves lives, rates of treatment drop out are very high. In addition, existing OUD treatments neglect the impact of untreated OUD on the family, and ignore the potential role family members and support persons (SPs) could have on encouraging long-term recovery. Incorporating the patient's support system may be an important way to improve treatment retention. The proposed study evaluates a counseling program for concerned family members, spouses, and friends called Community Reinforcement and Family Training (CRAFT), which is successful at engaging and retaining patients in substance use treatment. While promising, no studies have evaluated whether CRAFT can help patients remain on medication treatment for OUD, provided by community health clinics. If effective, this could save lives and help both patient and family member health outcomes. Patient and SP pairs will be recruited from community health clinics throughout northern and southern California. Patients taking OUD medication treatment will be recruited and randomly assign half of the SPs to receive CRAFT; the other half would receive treatment-as-usual. Patients and SPs will be interviewed three and twelve months later to evaluate whether patients with CRAFT SPs stay in OUD treatment longer, and whether patient and SP health outcomes improve.

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

盲法说明

Participants will be told which condition they are in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient inclusion criteria:
  • 18 and older
  • on buprenorphine treatment for OUD
  • has an eligible support person that participates
  • Support person inclusion criteria:
  • 18 and older
  • frequent contact with the patient
  • willing and available to try CRAFT

排除标准

  • < 18 years and older
  • not currently receiving buprenorphine
  • not able to provide consent
  • Support person exclusion criteria:
  • < 18 years and older
  • currently has a problem with heroin or opioid pills
  • not able to provide consent
  • actively using other substances such that their presence in group would be contraindicated

研究组 & 干预措施

Intervention

Experimental

Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.

干预措施: CRAFT (Behavioral)

Control

No Intervention

This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.

结局指标

主要结局

Patient buprenorphine retention

时间窗: 12 months after baseline

Percentage of patients who initiated OBOT who have at least 12 months of continuous treatment with buprenorphine with no more than a 7-day lapse between prescriptions

Patient buprenorphine retention

时间窗: 6 months after baseline

Percentage of patients who initiated OBOT who have at least 6 months of continuous treatment with buprenorphine with no more than a 7-day lapse between prescriptions

次要结局

  • Patient opioid and other substance use(3 months after baseline)
  • Patient and Support Person depression symptoms(12 months after baseline)
  • Patient and Support Person anxiety symptoms(12 months after baseline)
  • Patient opioid and other substance use(3 and 12 months after baseline)
  • Patient and Support Person depression symptoms(3 months after baseline)
  • Patient and Support Person anxiety symptoms(3 months after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Osilla

Principal Investigator

Stanford University

研究点 (12)

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