Brief Introductory Therapy for Opioid Dependence

描述（由申请人提供）： 收缩和行为激活疗法（CBAT）是一种介绍性治疗，旨在防止相当大的亚组患者进入美沙酮维持治疗（MMT），持续抑郁症状或士气低落，但不符合重度抑郁症的综合征标准。CBAT是一种高度结构化、手动驱动的处方性治疗，可由MMT的常规药物咨询师提供，并使用短期行为收缩和激活程序以及积极的框架建议来帮助患者实现最初的禁欲期，增加活动水平，并通过实现特定的短期行为目标，对抗对成功可能性的悲观情绪。本研究的数据支持培训常规MMT药物咨询师提供CBAT的可行性，以及与接受常规药物咨询或专业治疗（历史对照）的2个类似患者队列相比，CBAT（在美沙酮诱导后的前4周内提供6次治疗）减少非法阿片类药物使用的潜在疗效。本Ib期申请提出了一项为期12周的随机临床试验，以获得CBAT与同期对照、手册指导的美沙酮药物咨询（MDC）（接近标准MMT药物咨询）相比的疗效数据（具体目标1）;最后确定治疗手册、培训程序和材料，以及治疗能力和依从性评级量表（具体目标2）;以及评估提供治疗的药物顾问的手动依从性和熟练程度以及区分CBAT和MDC的能力（具体目标3）。具有持续抑郁症状（美沙酮诱导2周后BDI>16）的患者（N=60）将被随机分配至CBAT 4周，随后为MDC或从治疗开始即分配至MDC。CBAT和MDC将由MMT的常规药物顾问提供。将通过每周两次尿液毒理学检测和每周自我报告评估非法阿片类药物使用的减少。治疗录像带的独立评级将评估手动依从性和性能，并将用于评估评级的可靠性和评级量表区分CBAT和MDC的能力。从研究中获得的数据将用于评价CBAT和MDC之间差异的效应量，以确定比较CBAT和MDC的II期研究所需的样本量。

DESCRIPTION (provided by applicant): Contracting and Behavioral Activation Therapy (CBAT) is an introductory treatment designed to prevent treatment failure for the sizable subgroup of patients entering methadone maintenance treatment (MMT) with persistent depressive symptoms or demoralization but who do not meet syndromal criteria for Major Depression. CBAT, a highly structured, manual driven, prescriptive treatment, can be provided by regular drug counselors in MMT and uses short-term behavioral contracting and activation procedures and positively framed advice to help patients achieve an initial period of abstinence, increase activity levels, and, through accomplishment of specific, short-term behavioral goals, counter pessimism about the possibility of success. Data from the current study support the feasibility of training regular MMT drug counselors to provide CBAT and the potential efficacy for reducing illicit opiate use of CBAT (provided in 6 sessions during the first 4 weeks following methadone induction) compared to 2 cohorts of similar patients treated with regular drug counseling or professional therapy (historical controls). This Stage Ib application proposes a 12-week, randomized clinical trial to obtain data regarding the efficacy of CBAT compared to concurrent control, manual-guided Methadone Drug Counseling (MDC), that approximates standard MMT drug counseling (Specific Aim 1); to finalize treatment manuals, training procedures and materials, and a competence and adherence rating scale for the treatments (Specific Aim 2); and to evaluate manual adherence and proficiency of drug counselors providing the treatments and the ability to discriminate between CBAT and MDC (Specific Aim 3). Patients (N=60) with persistent depressive symptoms (BDI>16 following 2 weeks of methadone induction) will be randomly assigned to CBAT for 4 weeks followed by MDC or to MDC from the outset of treatment. CBAT and MDC will be provided by regular drug counselors in MMT. Reductions in illicit opioid use will be assessed by twice weekly urine toxicology testing and weekly self-report. Independent ratings of therapy videotapes will assess manual adherence and performance and will be used to assess the reliability of the ratings and the ability of the rating scales to discriminate between CBAT and MDC. Data obtained from the study will be used to evaluate the effect size of the differences between CBAT and MDC to determine the necessary sample size for a Stage II study comparing CBAT and MDC.