Advancing STOP: Self-regulation/CBT Therapy for Opioid addiction and Pain

推进停止：针对阿片类药物成瘾和疼痛的自我调节/CBT 疗法

• 批准号: 9244192
• 负责人: AMY B WACHHOLTZ
• 金额: $ 24.03万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-01 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9244192
• 关键词: Abstinence; Address; Adult; Aftercare; Behavioral; Centers for Disease Control and Prevention (U.S.); Chronic; Cognitive; Cognitive Therapy; Communities; Data; Drug usage; Epidemic; Feedback; Group Therapy; Human; Informal Social Control; Intervention; Laboratories; Laboratory Finding; Manuals; Measures; Mediation; Modeling; National Institute of Drug Abuse; Opiate Addiction; Opiates; Opioid; Pain; Pain Threshold; Pain management; Participant; Patients; Pharmaceutical Preparations; Physiological; Pilot Projects; Preparation; Professional counselor; Program Development; Protocols documentation; Provider; Psychophysiology; Psychotherapy; Randomized Controlled Trials; Relapse; Reporting; Role; Sampling; System; Testing; Therapeutic; Time; Training; Treatment Protocols; addiction; base; behavioral response; chronic pain; cohort; community setting; craving; design; field study; follow-up; improved; individualized medicine; innovation; medication-assisted treatment; novel; opioid abuse; opioid use; opioid use disorder; post intervention; prescription opioid abuse; primary outcome; psychologic; public health relevance; relapse patients; research study; response; standard of care; substance abuse treatment; therapy development; treatment as usual; treatment center; trial comparing

2. Specific Aims Among the more than half million adults entering addiction treatment for prescription opioid abuse every year, 50%-60% report co-morbid chronic pain1-3 and 80% of those patients report that pain triggers use.4 Fifty- four percent of patients report pain after treatment for opioid use disorder, and patients with co-morbid chronic pain are 5 times more likely to relapse to opiate use than those without.5 Opioid use disorder accounts for 1/3 of all substance abuse treatment in the US. However, treatment for opioid addiction is failing; 80% of patients relapse to daily opioid use within 1 year9. Despite the prominent role of chronic pain in opioid addiction, no empirically-developed integrated treatments address these co-morbid functionally related problems.10-12 This R34 proposal, “Advancing STOP: Self-regulation/CBT Therapy for Opioid addiction and Pain” in response to PA-13-078, “Behavioral and Integrative Treatment Development Program,” seeks to modify and further evaluate our innovative Cognitive Behavioral Therapy (CBT)+Self Regulation group therapy protocol (Self-regulation/CBT Therapy for Opioid addiction and Pain: STOP) initially developed from PI’s NIDA K-23 human laboratory findings on the psychological and physiological responses to pain and opioid craving. The PI’s NIDA K23, entitled Co-morbid Opioid Addiction and Chronic Pain, used a human laboratory paradigm to identify the unique treatment needs of opioid addicted adults with chronic pain, including a need for an integrated treatment to improve both pain and craving tolerance (i.e. not just pain sensitivity), and to develop adaptive cognitive hyper-control and new automatic psycho-physiological craving trigger responses similar to the responses found among co-morbid pain and addiction patients who have maintained long-term opioid abstinence.6 The human laboratory findings6 derived in the first 3 years of the K23 were then used develop “STOP,” the first iteration of an integrated group therapy treatment protocol designed to synergistically treat co-morbid opioid addiction and chronic pain over 12 weekly sessions to be used within the context of Medication Assisted Treatment in community addiction treatment centers. The model is thus designed to ease dissemination within existing community medication treatment models, Preliminary pre-post data from the K23 cohort of 14 subjects treated with STOP suggest high levels of acceptability of the protocol, improved pain tolerance, decreased cravings, and less drug use. In addition, subjects provided feedback to improve the protocol. The current R34 application is the next logical step to:1)modify the treatment manual and participant workbook based on the data derived from the initial K23 testing; 2)develop a clinician training protocol to train addiction counselors and treatment integrity measures which expands the K23 study in which the PI (Wachholtz) was the primary study therapist; 3)test the modified manual in a cohort of 10 subjects and modify once more if necessary, and 4)test the modified protocol in a Stage 1b Randomized Controlled Trial (RCT) with 50 subjects using primary outcomes of reduced opioid cravings and use, improved pain tolerance, and increased functional activity via mechanisms of improved pain and craving responses. Four specific aims are proposed: Specific Aim 1 (Stage 1a). Finalize the STOP therapist manual and participant workbook by merging quantitative and qualitative subject response data from the K23 pilot study to modify the initial K23 manual, and then test it on a 10 subject cohort. The protocol will then be refined again in response to subject feedback and quantitative data to yield a final 12-session, community friendly, stand alone, rolling entry psychotherapy manual that can be used within established substance abuse treatment delivery systems, and will simultaneously and integratively address therapeutic challenges of both chronic pain and addiction. Specific Aim 2. Develop and field test a clinician training protocol for addiction counselors who have no prior expertise in pain management, as well as treatment integrity measures for the treatment manual. Specific Aim 3 (Stage 1b). Complete small scale (N=50) Randomized Controlled Trial (RCT) comparing the new STOP protocol (n=25) to the current standard of care (“Treatment as Usual,” TAU; n=25) for opiate addiction in a sample of subjects with co-morbid opioid use disorder and chronic pain to establish initial effect sizes in preparation for a larger trial.13 TAU will include psychotherapy as provided by addiction providers; the STOP protocol will include STOP. There will be 3 assessment time points: pre-intervention, immediately post- intervention, and 1 month follow-up to assess for short term and longer term effects of the protocol. Specific Aim 4. To preliminarily test a mediation path from increased use of adaptive cognitive and behavioral responses, to pain and addiction cravings, to increased pain tolerance, decreased cravings and increased engagement in daily activities, to reduced drug use for use in preparation for future research studies.

2.具体目标 在50多万因处方阿片类药物滥用而接受成瘾治疗的成年人中， 50%-60%的患者报告合并慢性疼痛1 -3，其中80%的患者报告疼痛触发使用。 4%的患者在阿片类药物使用障碍治疗后报告疼痛， 阿片类药物使用后疼痛复发的可能性是未使用者的5倍。5阿片类药物使用障碍占1/3 美国所有药物滥用治疗的最高水平然而，阿片类药物成瘾的治疗是失败的; 80%的患者 1年内复发至每日使用阿片类药物9。尽管慢性疼痛在阿片类药物成瘾中起着重要作用， 医学上开发的综合治疗方法解决了这些并发的功能相关问题。10 -12 这一R34提案，“推进停止：阿片类药物成瘾和疼痛的自我调节/CBT治疗”， 对PA-13-078“行为和综合治疗开发计划”的回应旨在修改和 进一步评估我们创新的认知行为疗法（CBT）+自我调节小组治疗方案 （自我调节/阿片类药物成瘾和疼痛的CBT疗法：STOP）最初由PI的NIDA K-23开发 人类实验室对疼痛和阿片类药物渴求的心理和生理反应的研究结果。的 PI的NIDA K23，题为共同病态阿片类药物成瘾和慢性疼痛，使用人类实验室范例， 确定患有慢性疼痛的阿片类成瘾成年人的独特治疗需求，包括需要 综合治疗，以改善疼痛和渴望耐受性（即不仅仅是疼痛敏感性），并发展 适应性认知超控制和新的自动心理生理渴望触发类似于 在长期维持阿片类药物的共病疼痛和成瘾患者中发现的反应 禁欲。 K23前3年得出的人类实验室发现6随后被用于开发“STOP”，即 设计用于协同治疗共病的综合团体疗法治疗方案的第一次迭代 阿片类药物成瘾和慢性疼痛超过12周，用于药物治疗 社区戒毒中心的辅助治疗。该模型旨在缓解 现有社区药物治疗模式内的传播，来自K23的初步前后数据 接受STOP治疗的14例受试者队列表明方案的可接受性较高，疼痛改善 耐受性，减少渴望，减少药物使用。此外，受试者提供反馈，以改善 议定书当前的R34应用程序是下一个合乎逻辑的步骤：1）修改治疗手册和参与者 基于初始K23测试数据的工作簿; 2）制定临床医生培训方案， 成瘾咨询师和治疗完整性措施，扩大了K23研究，其中PI （Wachholtz）是主要的研究治疗师; 3）在10名受试者的队列中测试修改后的手册，并修改 必要时再进行一次，以及4）在1b期随机对照试验（RCT）中测试修改后的方案， 50例受试者使用阿片类药物渴求和使用减少、疼痛耐受性改善的主要结局，以及 通过改善疼痛和渴望反应的机制增加功能活动。 提出了四个具体目标： 具体目标1（阶段1a）。通过合并STOP治疗师手册和参与者工作手册， K23初步研究的定量和定性受试者缓解数据，以修改初始K23手册，以及 然后在10名受试者队列中进行测试。然后将根据受试者反馈再次完善方案， 量化数据，以产生最终的12个疗程，社区友好，独立，滚动进入心理治疗 可在已建立的药物滥用治疗提供系统中使用的手册， 同时和综合地解决慢性疼痛和成瘾的治疗挑战。 具体目标2。为没有前科的成瘾咨询师制定并现场测试临床医生培训方案 疼痛管理方面的专业知识，以及治疗手册的治疗完整性措施。 具体目标3（阶段1b）。完成小规模（N=50）随机对照试验（RCT），比较 阿片类药物现行标准治疗（“作为药物治疗”，TAU; n= 25）的新STOP方案（n =25） 在患有阿片类药物使用障碍和慢性疼痛共病的受试者样本中成瘾，以确定初始效应 13 TAU将包括由成瘾提供者提供的心理治疗; STOP协议将包括STOP。将有3个评估时间点：干预前、干预后即刻、 干预和1个月随访，以评估方案的短期和长期效果。 具体目标4。初步测试从增加使用适应性认知和行为 反应，疼痛和成瘾的渴望，增加疼痛耐受性，减少渴望和增加 参与日常活动，以减少药物使用，为未来的研究做准备。