Combined Treatment for Cocaine-Alcohol Dependence

描述(申请人提供)：寻求治疗的可卡因和酒精依赖患者预后很差。虽然没有特别有效的药物，但药物和心理疗法的结合可能被证明是有效的。纳曲酮(NTX)被批准用于酒精依赖，可能会在较高剂量(&gt；50 mg/d)下阻止可卡因-酒精奖励效应，但心理治疗背景是关键。我们的初步工作表明，当NTX与复发预防(RP)治疗和应急管理程序(CMP)相结合时，NTX具有潜在的用途。我们提出了一项大型、双盲、安慰剂对照、全因素研究，以检验RP+CMP联合NTX治疗可卡因-酒精依赖的作用。可卡因依赖的门诊患者(N=140)将被随机分配到NTX 100 mg/d或安慰剂合并两种心理治疗条件(RP或RP+CMP)中的一种。标准化的同意和服药程序之后将是单盲基线安慰剂周，然后是12周的试验，每周两次。手动引导的RP疗法将每周进行一次，每次60分钟。CMP将加强基于可卡因阴性尿检和呼气酒精测试阴性结果的戒酒。服药依从性将通过核黄素和药片计数进行监测。随访评估将在治疗结束后3、6、9和12个月进行。主要疗效变量将是物质使用(即尿液筛查、时间线跟踪方法、附带告密者、肝酶变化)和留存(即参加疗程的次数、辍学时间)的衡量标准。次要变量将包括成瘾严重程度和不良事件测量。第三组变量将作为治疗结果的可能预测因素进行测试。这些指标包括动机、自我效能、服药依从性、血清6-β纳曲醇水平、渴求、酒精问题家族史和依赖程度。功率足以检验主要假设，即NTX 100 mg/d配合RP+CMP将减少可卡因和酒精的使用。其次，我们将：(1)检查结果的可变性，作为一系列潜在预测因素的个体差异的函数；(2)使用创新的多项选择测量策略评估可卡因和酒精的相对强化；以及(3)检查治疗和后续期间可卡因和酒精使用之间的关系。

DESCRIPTION (provided by applicant): Treatment seeking patients who are cocaine and alcohol dependent have poor prognosis. While there are no uniquely effective medications, combined pharmaco- and psychotherapy may prove efficacious. Naltrexone (NTX), approved for alcohol dependence, may block cocaine-alcohol rewarding effects at higher doses (> 50 mg/d) but psychotherapeutic context is critical. Our preliminary work indicates potential utility of NTX when combined with Relapse Prevention (RP) therapy and Contingency Management Procedures (CMP). We propose a large, double-blind, placebo-controlled, full factorial study to examine the role of RP + CMP combined with NTX for treatment of cocaine-alcohol dependence. Cocaine-alcohol dependent outpatients (N = 140) will be randomly assigned to NTX 100 mg/d or placebo combined with one of two psychotherapy conditions (RP or RP + CMP). Standardized consent and intake procedures will be followed by a single-blind baseline placebo week and then a 12 week trial with twice weekly visits. Manual-guided RP therapy will be delivered weekly in 60-minute individual sessions. CMP will reinforce abstinence based on cocaine-negative urine screens and negative breath alcohol test results. Medication adherence will be monitored with riboflavin and pill counts. Follow-up assessments will be conducted at 3, 6, 9, and 12 months after treatment termination. Primary efficacy variables will be measures of substance use (i.e., urine screens, Time-Line Follow-Back methods, collateral informants, change in liver enzymes) and retention (i.e., number of sessions attended, time to dropout). Secondary variables will include addiction severity and adverse event measures. A third set of variables will be tested as possible predictors of therapeutic outcomes. These include measures of motivation, self-efficacy, medication compliance, serum 6-beta naltrexol levels, craving, family history of alcohol problems, and severity of dependence. Power is sufficient to test the main hypothesis that NTX 100 mg/d with RP + CMP will reduce cocaine and alcohol use. Secondarily we will: (1) examine outcome variability as a function of individual differences on a range of potential predictors; (2) evaluate relative reinforcement of cocaine and alcohol using an innovative multiple choice measurement strategy; and (3) examine the relationship between cocaine and alcohol use during treatment and follow-up.