Treatment of Cocaine Addiction with Integrative Meditation

描述（由申请人提供）：在美国，可卡因成瘾仍然是一个主要的公共卫生问题。由于没有FDA批准的药物治疗，治疗通常依赖于社会心理干预，即行为治疗。尽管取得了一些积极进展，但这些社会心理干预措施对高辍学率、未经治疗的身体症状和高复发率等问题的疗效有限。我们的临床经验和初步研究表明，中医综合冥想（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，这是典型行为疗法所错过的。IM是正念冥想的一种改编或简化形式。它可以加强现有的治疗方法，帮助减少戒断症状，增加治疗参与，并通过逐步的治疗师促进防止复发。这将是一项简短的1b期治疗发展研究，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随机对照试验，每周进行12次促进会议，以评估招募和留住可卡因成瘾者的可行性，并与非指导性治疗（NT）对照比较，确定im增强治疗与非指导性治疗（NT）对照的效应大小，两组均接受常规标准治疗（TAU）；(2)研究注意网络和负性情绪的变化是否可能是两组治疗结果的中介。治疗结果将在基线、第4周、第8周和第12周以及干预后3个月的随访时进行评估。主要结局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。本文还提出了其他措施，以帮助理解IM对注意网络和自主神经系统影响的可能潜在机制。一个在冥想和行为治疗发展方面经验丰富的多元化团队被聚集在一起，进行拟议的R21项目，并为全面的治疗发展研究做准备。

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.