Development of an integrated intervention involving recovery coaching and cognitive behavioral therapy for opioid use disorder

开发涉及阿片类药物使用障碍的恢复指导和认知行为治疗的综合干预措施

• 批准号: 10590299
• 负责人: MOONSEONG HEO
• 金额: $ 89.75万
• 依托单位: CLEMSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2025-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10590299
• 关键词: Abstinence; Address; Adherence; Affect; Aftercare; Assertiveness; Behavior; Behavioral; Buprenorphine; Caring; Cessation of life; Clinical Trials; Cognitive Therapy; Communities; Cues; Decision Making; Development; Drug usage; Economic Burden; Educational process of instructing; Effectiveness; Emergency department visit; Emotional; Enrollment; Evidence based intervention; Exhibits; Frequencies; Galvanic Skin Response; Health; Hospitalization; Illicit Drugs; Individual; Infection; Injections; Intervention; Interview; Laboratories; Measures; Methadone; Modeling; Motivation; Online Systems; Opioid; Outcome; Overdose; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Physiological; Pilot Projects; Population; Protocols documentation; Public Health; Randomized; Randomized Clinical Trials; Recovery; Respiration; Sampling; Self Efficacy; Services; Site; Social Interaction; Social support; Substance Use Disorder; Suggestion; Testing; Therapeutic; Training; Treatment outcome; United States; Universities; Urine; adverse outcome; arm; base; buprenorphine treatment; community engagement; comorbidity; cost; craving; cue reactivity; design; drug testing; efficacy evaluation; evidence base; experience; follow-up; heart rate variability; illicit drug use; implementation facilitators; improved; improved outcome; innovation; medication compliance; mortality; opioid epidemic; opioid overdose; opioid use; opioid use disorder; overdose risk; peer; peer support; polysubstance use; primary outcome; prisma; randomized trial; response; role model; severe mental illness; skills; social health determinants; standard of care; substance use; systematic review; treatment as usual

PROJECT SUMMARY/ABSTRACT Opioid use disorder (OUD) has led to an unprecedented public health crisis in the United States. An estimated 2.1 million people have opioid use disorder, although these numbers are likely to be underestimated. The opioid epidemic has caused a staggering toll in the US in terms of causing opioid-related overdoses, emergency department visits, and hospitalizations. Medications for opioid use disorder (MOUD), including methadone and buprenorphine, have proven to be effective pharmacologic strategies for treating OUD and are associated with decreased mortality. Unfortunately, retention to medication is suboptimal; only 56.8% of individuals who initiate buprenorphine are retained 6 months later. Another major issue in this population is related to multiple comorbid substance use disorders (SUDs). Thus, the incorporation of additional strategies in the buprenorphine protocols aimed at addressing these deficits is warranted. Cognitive-behavioral Therapy (CBT) is one of the most used interventions for treating SUDs and is broadly recognized as an evidence-based intervention. Unfortunately, studies to date have not demonstrated that adding in-person CBT to MOUD for treating OUD reduce drug use or increase treatment retention, attendance, or medication adherence. However, a recent study of web-based CBT (CBT4CBT-Buprenorphine) provided favorable results regarding the preliminary efficacy of CBT as an add-on to buprenorphine. Recovery coaching (RC) services provided by individuals with substance use experience and successful recovery involve a form of nonclinical, peer support aimed at helping individuals with SUDs to achieve and maintain recovery. In a recent systematic review, we demonstrated that the use of recovery coaches for people living with OUD is associated with increases in MOUD initiation, including buprenorphine and methadone. In addition, the utilization of recovery coaches was proven to be useful in decreasing opioid use. However, recovery coaches have not yet been shown to improve outcomes for those already on MOUD. In a small pilot study, we demonstrated that combining recovery coaching (with the model of Assertive Community Engagement) and CBT4CBT-Buprenorphine led to decreased illicit drug use and optimized social determinants of health. We propose an integrated intervention combining RC and CBT. We hypothesize that both components will improve behavioral skills with CBT4CBT-Buprenorphine teaching discrete skills and RC providing role modeling, reinforcing skills and practice, providing social support (emotional/informational, tangible, affectionate and positive social interaction), and motivating participants to complete modules and homework, which will result in decreased substance use and increased retention. The specific aims of this proposal are: (1) to conduct a 3-arm randomized clinical trial to evaluate the efficacy of the integrated Recovery Coach + CBT4CBT-Buprenorphine intervention vs. CBT4CBT- Buprenorphine vs. Treatment as Usual (N=90); (2) to investigate whether the integrated intervention reduces cue-reactivity and improves inhibitory control; (3) to refine our Recovery Coach + CBT4CBT-Buprenorphine intervention for a multi-site R01 clinical trial.

项目摘要/摘要 阿片类药物使用障碍（OUD）导致美国史无前例的公共卫生危机。一个 估计有210万人患有阿片类药物使用障碍，尽管这些数字可能被低估了。 阿片类药物流行在美国导致阿片类药物相关的过量， 急诊室就诊和住院。阿片类药物使用障碍（MOUD）的药物，包括 美沙酮和丁丙诺啡已被证明是治疗Oud的有效药理策略 与死亡率降低有关。不幸的是，对药物的保留是次优的。只有56.8％ 启动丁丙诺啡的个体在6个月后保留。该人群的另一个主要问题是 与多种合并症使用障碍（SUD）有关。因此，将其他策略纳入 有必要解决旨在解决这些赤字的丁丙诺啡协议。 认知行为疗法（CBT）是治疗SUD的最常用干预措施之一，IS 广泛被认为是基于证据的干预措施。不幸的是，迄今为止的研究尚未证明 增加了面对面的CBT来穆德治疗OUD减少药物使用或增加治疗保留率， 出席或药物依从性。但是，最近对基于Web的CBT的研究（CBT4CBT-鲍普诺啡） 关于CBT作为丁丙诺啡附加功能的初步疗效提供了有利的结果。 恢复教练（RC）服务由具有药物使用经验和成功的个人提供 恢复涉及一种非临床，同伴支持的形式，旨在帮助泡沫患者实现和 保持恢复。在最近的系统评论中，我们证明了为人们使用恢复教练 与OUD一起生活与包括丁丙诺啡和美沙酮在内的MOUD启动的增加有关。在 此外，事实证明，恢复教练的利用可用于减少阿片类药物的使用。但是，恢复 尚未证明教练可以改善穆德（Moud）上的人们的成果。在一项小型试点研究中，我们 证明将恢复教练（与自信的社区参与模式结合在一起）和 CBT4CBT-美丽吗啡导致非法药物使用降低，并优化了健康的社会决定因素。 我们提出了将RC和CBT结合的综合干预措施。我们假设两个组件 将通过CBT4CBT-布替诺彭教学离散技能提高行为能力，并发挥作用 建模，加强技能和实践，提供社会支持（情感/信息，有形，深情 和积极的社交互动），并激励参与者完成模块和作业，这将导致 在减少药物使用和增加的保留率中。 该提案的具体目的是：（1）进行3臂随机临床试验以评估 综合恢复教练 + CBT4CBT-布肾上谢干预的功效与CBT4CBT- 丁丙诺啡与往常一样（n = 90）； （2）调查综合干预措施是否减少 提示反应性并改善抑制性控制； （3）完善我们的恢复教练 + CBT4CBT-布内啡吗啡 多站点R01临床试验的干预。