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)在美国导致了前所未有的公共健康危机。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。 阿片类药物的流行在美国造成了惊人的死亡，导致与阿片类药物相关的过量， 急诊科就诊和住院治疗。治疗阿片类药物使用障碍(Moud)，包括 美沙酮和丁丙诺啡已被证明是治疗OUD和AUD的有效药物策略 与降低死亡率有关。不幸的是，药物保留率并不理想；只有56.8%的人 开始服用丁丙诺啡的人在6个月后仍被保留。这个人口中的另一个主要问题是 与多种共病物质使用障碍(SUDS)有关。因此，将更多的战略纳入 旨在解决这些缺陷的丁丙诺啡议定书是必要的。 认知行为疗法(CBT)是治疗肥皂症和IS最常用的干预措施之一 被广泛认为是一种基于证据的干预。不幸的是，到目前为止的研究还没有证明 将面对面CBT用于治疗OUD减少药物使用或增加治疗保留率， 出诊，或服药依从性。然而，最近一项基于网络的CBT(CBT4CBT-丁丙诺啡)研究 提供了关于CBT作为丁丙诺啡附加物的初步疗效的有利结果。 康复教练(RC)服务由有药物使用经验和成功的个人提供 康复涉及一种非临床的同伴支持形式，旨在帮助患有肥胖症的个人实现和 保持复苏。在最近的一次系统回顾中，我们证明了对人们使用康复教练 与OUD一起生活与Moud启蒙的增加有关，包括丁丙诺啡和美沙酮。在……里面 此外，事实证明，使用康复教练有助于减少阿片类药物的使用。然而，复苏 教练还没有被证明能改善那些已经服用Moud的人的结果。在一项小型先导研究中，我们 演示了将康复指导(与主动性社区参与模式)和 CBT4CBT-丁丙诺啡减少了非法药物的使用，优化了健康的社会决定因素。 我们提出了RC和CBT相结合的综合干预方案。我们假设这两个组件 将通过CBT4CBT-丁丙诺啡教授离散技能和RC提供角色来提高行为技能 建模，加强技能和实践，提供社会支持(情感/信息，有形的，深情的 和积极的社交互动)，并激励参与者完成单元和家庭作业，这将导致 在减少物质使用和增加保留量方面。 这项建议的具体目的是：(1)进行一项三臂随机临床试验，以评估 综合康复教练+CBT4CBT-丁丙诺啡干预与CBT4CBT干预的疗效比较 丁丙诺啡与常规治疗(N=90)；(2)调查综合干预是否减少 提示反应性和改善抑制控制；(3)完善我们的康复教练+CBT4CBT-丁丙诺啡 一项多点R01临床试验的干预。