Opioid Patients: Behavioral Family Counseling and Naltrexone

描述（由申请人提供）： 尽管药理学疗效已被证实，纳洛酮在治疗阿片类药物依赖方面几乎没有用处，因为患者依从性差，我们在这个拟议的项目中解决了这个问题。在行为家庭咨询（BFC）和纳洛酮的第一项研究中，我们将与家庭成员一起生活的男性阿片类药物依赖患者随机分配到同等强度的治疗：（a）BFC，家庭成员观察患者每天服用纳洛酮加基于个体的治疗（IBT）或（B）IBT。与IBT患者相比，BFC患者摄入了更多剂量的纳洛酮，参加了更多的治疗疗程，戒断时间更长，并且在治疗期间和治疗后一年内戒断阿片类药物和其他非法药物的天数明显更多。在1年随访时，BFC患者的药物相关法律的和家庭问题也明显较少。 拟议的项目将进行一项更全面的随机临床试验，比较3种干预措施，每种干预措施包括纳洛酮（50 mg/天）处方和标准化的依从性增强方法加上个体药物咨询（IDC）。寻求门诊免费治疗的阿片类药物依赖患者（N=225）（a）行为家庭咨询，其中家庭成员观察患者的每日纳洛酮摄入（BFC-NAL）加上IDC;（B）行为家庭咨询（BFC），不对纳洛酮摄入加IDC进行家庭观察;或（c）单独对患者进行IDC。我们将检验以下预测：两种家庭治疗条件均优于单独IDC，每日观察纳洛酮的家庭咨询优于无观察的家庭咨询（即BFC-NAL > BFC > IDC）对（a）阿片类药物戒断率更高的主要结局;（B）纳洛酮依从性更高和治疗保留时间更长的中间结局;和（c）次要结果是更多的阿片类药物以外的药物戒断，更积极的家庭和心理社会功能，以及更少的艾滋病毒风险行为。将在治疗期间、治疗后即刻和治疗后12个月的季度随访时从患者和家庭成员中收集结局数据。

DESCRIPTION (provided by applicant): Despite proven pharmacological efficacy, naltrexone has had little use in treating opioid dependence because of poor patient compliance, the problem we address in this proposed project. In the first study of Behavioral Family Counseling (BFC) and naltrexone, we randomly assigned male opioid dependent patients who were living with a family member to equally intensive treatments: (a) BFC with a family member observing the patient take naltrexone daily plus individual-based treatment (IBT) or (b) IBT only. BFC patients, compared with their IBT counterparts, ingested more doses of naltrexone, attended more treatment sessions, stayed abstinent longer, and had significantly more days abstinent from opioids and other illicit drugs during treatment and in the year after treatment. BFC patients also had significantly fewer drug related legal and family problems at 1-year follow-up. The proposed project will conduct a more comprehensive randomized clinical trial comparing 3 interventions each of which includes a prescription for naltrexone (50mg/day) with a standardized compliance enhancement method plus individual drug counseling (IDC). Opioid dependent patients (N=225) seeking outpatient drug free treatment (generally immediately post-detoxification) will be randomly assigned to 24 treatment sessions over a 16-week period consisting of either: (a) behavioral family counseling in which a family member observes the patient's daily naltrexone ingestion (BFC-NAL) plus IDC; (b) behavioral family counseling (BFC) without family observation of naltrexone ingestion plus IDC; or (c) IDC for the patient alone. We will test the prediction that both family treatment conditions will do better than IDC alone and that family counseling with daily observed naltrexone will do better than family counseling without such observation (i.e. BFC-NAL > BFC > IDC) on (a) primary outcomes of greater abstinence from opioids; (b) intermediate outcomes of greater naltrexone compliance and longer retention in treatment; and (c) secondary outcomes of more abstinence from drugs other than opioids, more positive family and psychosocial functioning, and fewer HIV risk behaviors. Outcome data will be collected from patients and family member collaterals during treatment, immediately posttreatment, and at quarterly follow-ups for 12 months after treatment.