Opioid Patients: Behavioral Family Counseling and Naltrexone

阿片类药物患者：行为家庭咨询和纳曲酮

• 批准号: 7483202
• 负责人: TIMOTHY JAMES O'FARRELL
• 金额: $ 47.85万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-20 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7483202
• 关键词: Abstinence; Address; Aftercare; Alcohol or Other Drugs use; Area; Behavior; Behavior Therapy; Behavioral; Clinical Trials; Cognitive Therapy; Condition; Contracts; Counseling; Daily; Data; Doctor of Philosophy; Dose; Drug Metabolic Detoxication; Drug usage; Effectiveness; Family; Family Relationship; Family member; Family psychotherapy; Female; HIV; Health Personnel; Illicit Drugs; Individual; Ingestion; Intervention; Legal; Life; Manuals; Measures; Mediating; Methods; Naltrexone; Opiate Addiction; Opioid; Outcome; Outpatients; Parents; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Randomized; Reporting; Risk Behaviors; Role; Social Functioning; Spouses; Testing; Week; addiction; base; compliance behavior; day; design; drug abstinence; follow-up; high risk behavior; male; member; men; prescription document; prescription procedure; psychosocial; trial comparing

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.

描述(由申请人提供)： 尽管纳曲酮的药理疗效已被证明，但由于患者依从性差，纳曲酮在治疗阿片类药物依赖方面几乎没有什么用处，这是我们在这个拟议项目中解决的问题。在第一项关于行为家庭咨询(BFC)和纳曲酮的研究中，我们随机将与家人生活在一起的男性阿片依赖患者分配到同等强度的治疗中：(A)行为家庭咨询(BFC)，家庭成员观察患者每天服用纳曲酮加基于个人的治疗(IBT)或仅接受IBT。与IBT患者相比，BFC患者摄入更多剂量的纳曲酮，参加更多的治疗疗程，戒断时间更长，在治疗期间和治疗后一年内戒除阿片类药物和其他非法药物的天数显著增加。在1年的随访中，BFC患者与药物有关的法律和家庭问题也明显减少。 拟议的项目将进行一项更全面的随机临床试验，对3种干预措施进行比较，每种干预措施都包括纳曲酮处方(50 mg/天)和标准化依从性增强方法加上个别药物咨询(IDC)。寻求门诊无药物治疗的阿片依赖患者(N=225)将被随机分配到24个治疗疗程，为期16周，其中包括：(A)家庭行为咨询，其中家庭成员观察患者的日常纳曲酮摄入量(BFC-NAL)和IDC；(B)没有家庭观察纳曲酮摄入量和IDC的行为家庭咨询(BFC)；或(C)单独对患者进行IDC。我们将检验这两种家庭治疗条件将比单独使用IDC更好的预测，以及使用每日观察的纳曲酮的家庭咨询将在(A)更大程度上戒除阿片类药物的主要结果；(B)更大的纳曲酮依从性和更长的治疗保留时间的中期结果；以及(C)更多戒除阿片类药物的次要结果，更积极的家庭和心理社会功能，以及更少的艾滋病毒危险行为。结果数据将在治疗期间、治疗后立即和治疗后12个月的季度随访中从患者和家庭成员侧支收集。