Employment-Based Depot Naltrexone Clinical Trial

描述（由申请人提供）：海洛因成瘾会造成毁灭性的社会、医疗和经济后果。美沙酮维持是一种有效的治疗海洛因成瘾的方法，但只有大约20%的鸦片依赖者接受这种治疗。纳曲酮是一种阿片类拮抗剂，对许多人来说是一种有效的替代药物。然而，由于患者接受度差，它的效用受到限制。最近开发的纳曲酮缓释制剂可提供长达6周的阿片类拮抗剂，并简化纳曲酮的依从性。然而，考虑到大多数患者对口服纳曲酮的排斥反应，需要同时进行行为治疗以鼓励患者持续服用纳曲酮。计划进行一项随机研究，以评估治疗场所在促进失业阿片类依赖成人使用仓库纳曲酮方面的有效性。治疗性工作场所是一种新型的基于就业的干预措施，利用工作工资来加强临床重要的行为改变；该方法已在其他应用中得到有效应用。在这个模范工作场所，滥用药物的病人被雇佣并获得报酬。为了促进理想的行为，工资是根据工作和其他行为而定的。志愿者海洛因依赖成人将提供住院戒毒和纳曲酮诱导。完成入职的参与者（N=80）将服用6个月的仓库纳曲酮，邀请他们在治疗场所工作，并随机分配到两组中，这两组的工作偶然性和收入水平不同。在“工作场所加纳曲酮应急”条件下，患者将获得进入工作场所和赚取工资，每月服用一次仓库纳曲酮。“工作场所加纳曲酮处方”的参与者将被鼓励服用库存纳曲酮，但获得工作和收入的机会将不取决于这样做。在为期6个月的试验中，将评估仓库纳曲酮和阿片类药物使用的关键接受措施。

DESCRIPTION (provided by applicant): Heroin addiction can have devastating social, medical and economic consequences. Methadone maintenance is an effective treatment for heroin addiction, but only about 20 percent of opiate dependent individuals receive it. Naltrexone is an opiate antagonist that could be an effective alternative for many individuals. However, its utility has been limited by poor patient acceptance. Recently developed extended-release depot formulations of naltrexone provide opiate antagonism for up to 6 weeks and simplify naltrexone adherence. However, given the rejection of oral naltrexone by most patients, concurrent behavioral treatment will be needed to encourage patients to take the depot consistently. A randomized study is planned to evaluate the effectiveness of the Therapeutic Workplace in promoting use of depot naltrexone in unemployed opiate-dependent adults. The Therapeutic Workplace is a novel employment based intervention that uses salary for work to reinforce clinically important behavior change; it has been shown effective in other applications. Drug abuse patients are hired and paid in this model workplace. To promote desirable behaviors, salary is made contingent both on work and on those other behaviors. Volunteer heroin dependent adults will be provided inpatient detoxification and naltrexone induction. Participants who complete the induction (N=80) will be prescribed depot naltrexone for 6 months, invited to work in the Therapeutic Workplace, and randomly assigned to one of two groups that will differ in the contingencies for working and earning salary. Patients in the "Workplace Plus Naltrexone Contingency" condition will earn access to the workplace and to earning salary by taking depot naltrexone once per month. "Workplace Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone, but access to working and earning salary will not be not contingent on doing so. Critical measures of acceptance of depot naltrexone and opiate use will be assessed over the 6-month trial. This study will provide a rigorous evaluation of a novel employment-based intervention, the Therapeutic Workplace, to promote use of depot naltrexone and to promote opiate abstinence in heroin dependent individuals who are at considerable risk for persistent and long-term opiate addiction.