Treatment of Cocaine Addiction with Integrative Meditation

描述（由申请人提供）：可卡因成瘾仍然是美国的一个主要公共卫生问题。由于没有FDA批准的药物治疗，治疗通常依赖于心理社会干预，即行为治疗。尽管取得了一些积极进展，但这些心理社会干预措施的效力有限，存在辍学率高、身体症状得不到治疗和复发率高等问题。我们的临床经验和试点研究表明，中医的综合冥想（IM）可以帮助客户参与治疗，减少渴望/戒断症状，并增加治疗保留，这似乎是典型的行为疗法所错过的。IM是一种适应或简化形式的正念冥想。它可以增强现有的治疗方法，以帮助减少戒断症状，增加治疗参与，并通过逐步治疗师促进来防止复发。这将是一项简短的1b期治疗开发研究，基于初步治疗师手册和观察性研究。具体目标包括：（1）对66名门诊可卡因使用者进行一项试点随机对照试验，每周进行12次促进会议，以评估招募和保留可卡因成瘾者的可行性，并确定IM增强治疗与非指导性治疗（NT）对照相比的效果大小，两组均接受常规标准治疗（TAU），（2）探讨两组患者注意网络和负性情绪的变化是否是影响治疗效果的可能中介因素。将在基线、第4、8和12周以及干预后3个月随访时评估治疗结局。主要结果包括可卡因尿液毒理学，治疗周数和可卡因使用强度。次要结局指标包括成瘾严重程度指数（ASI）综合评分、酒精和其他药物的使用、心率变异性、渴望、抑郁、焦虑和自我效能。提出了额外的措施，以帮助了解可能的潜在机制，IM的注意力网络和自主神经系统的影响。一个在冥想和行为疗法开发方面经验丰富的多元化团队聚集在一起，进行拟议的R21项目，并为全面的疗法开发研究做准备。 公共卫生相关性：鉴于可卡因成瘾仍然是美国的一个主要公共卫生问题，没有一个合理的解决方案，拟议的研究将实施一项简短的第一阶段研究，将综合冥想（IM）作为目前门诊治疗的自我护理组成部分，以改善可卡因成瘾的治疗结果。IM需要最小的治疗师参与，可以作为其他现有治疗方式的辅助手段。它不仅可以在患者需要时为戒断或禁欲期间的身体和心理症状提供所需的治疗，而且还可以快速吸引患者参与治疗，并改善患者的自我效能和注意力网络，有助于防止他们复发。因此，如果研究验证了其有效性和可行性，IM可能会成为成瘾治疗领域的一个重要的成本效益工具。

DESCRIPTION (provided by applicant): Cocaine addiction continues to be a major public health problem in the U.S. With no FDA- approved pharmaceutical therapy, treatment often relies on psychosocial interventions, known as behavior therapy. Despite some positive progress these psychosocial interventions have limited efficacy with problems like high dropout, untreated physical symptoms and high relapse rate. Our clinical experience and pilot studies suggest that Integrative Meditation (IM) from Chinese medicine may help clients engage in treatment, reduce cravings/ withdrawal symptoms, and increase treatment retention, which appear missed by a typical behavior therapy. IM is an adaptation or simplified form of mindfulness meditation. It may enhance existing therapies to help reduce withdrawal symptoms, increase treatment engagement, and prevent relapse through step-by-step therapist facilitation. This will be a brief Stage-1b therapy development study, based on a preliminary therapist manual and an observational study. The specific aims include: (1) To conduct a pilot randomized controlled trial of 66 outpatient cocaine users with 12 weekly facilitation meetings to assess feasibility of recruiting and retaining cocaine addicts, and to determine effect size of IM-augmented treatment in comparison with Non-directive therapy (NT) control, with both groups receiving standard treatment as usual (TAU), (2) To examine the changes in attention networks and negative mood as possible mediators of treatment outcomes between the two groups. Treatment outcomes will be assessed at baseline, week 4, 8 and 12, and at the follow-up 3 months after intervention. Primary outcomes include cocaine urine toxicology, number of weeks in treatment, and intensity of cocaine use. Secondary outcome measures include Addiction Severity Index (ASI) composite scores, use of alcohol and other drugs, heart rate variability, craving, depression, anxiety, and self-efficacy. Additional measures are proposed to aid in understanding possible underlying mechanisms of IM's effect on attention networks and the autonomic nervous system. A diverse team experienced in meditation and behavior therapy development is brought together to conduct the proposed R21 project, and prepare for a full therapy development study. PUBLIC HEALTH RELEVANCE: Given the fact that cocaine addiction continues to be a major public health problem in the U.S. without a sound solution, the proposed study will implement a brief Stage-I study of adding Integrative Meditation (IM) as a self-care component to the current outpatient treatment to improve treatment outcome for cocaine addiction. IM requires minimum therapist involvement and can serve as an adjunct to other existing treatment modalities. It may not only provide the needed treatment for physical and psychological symptoms during withdrawal or abstinence at the time when a patient needs it, but also quickly engage patients in the treatment and improve patients' self-efficacy and attention network that could help keep them away from relapse. Therefore, if the study verifies its efficacy and feasibility, IM may become an important cost- effective tool in the field of addiction treatment.