Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care
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
- 是
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
Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.
干预措施: CRAFT (Behavioral)
Control
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
Karen Osilla
Principal Investigator
Stanford University
