Employment-based Depot Naltrexone Clinical Trial

描述（由申请人提供）：注射海洛因使用是一个慢性问题，通过危险的注射行为助长了艾滋病毒/艾滋病的传播。美沙酮和丁丙诺啡可以减少海洛因的使用和危险的注射行为;然而，它们具有滥用潜力，产生身体依赖性，可以产生致命的过量，受到高度管制，一些患者根本不想要激动剂治疗。阿片类药物脱毒可以作为激动剂治疗的替代方法，但许多注射吸毒者在脱毒后重新使用海洛因并恢复危险的注射行为。Vivitrol（R）是一种纳洛酮的缓释制剂，最近被FDA批准用于治疗阿片类药物依赖，但由于许多阿片类药物依赖的成年人不愿意维持其治疗，因此其临床效用尚不确定。 长期使用，以及一些患者在纳洛酮阻断下继续使用阿片类药物的事实。我们在该补助金第一阶段的研究表明，基于就业的强化可以非常有效地促进长期坚持Vivitrol（R）。基于就业的强化可能非常适合于解决延长释放纳洛酮的局限性，通过利用其潜力，同时加强纳洛酮的依从性和阿片类药物戒断。这笔赠款将评估以就业为基础的强化的有效性，以同时促进Vivitrol（R）的高依从率和增加阿片类药物的戒断。在这项为期5年的研究中，我们建议评估FDA批准的缓释纳洛酮（Vivitrol（R））制剂和基于就业的阿片类药物戒断强化在促进阿片类药物戒断和减少最近脱毒的阿片类药物依赖性注射吸毒者中的危险注射行为方面的单独和联合作用。在阿片类药物解毒和诱导口服纳洛酮后，参与者将被邀请参加治疗工作场所24周（在那里他们可以工作和赚取工资），并将被随机分配到四个组中的一个，这四个组的不同之处在于他们是否接受Vivitrol（R），基于就业的阿片类药物戒断强化，两者兼而有之。Vivitrol（R）条件的参与者将被要求定期注射工作和赚取工资。暴露于阿片类药物戒断强化的参与者如果不能提供无阿片类药物的尿液样本，将暂时降低其工作场所的工资。这项研究将评估干预措施对每周阿片类药物尿分析结果的影响，以及对注射毒品使用和可卡因使用的影响。如果这项研究表明，Vivitrol（R）和基于就业的坚持和阿片类药物戒断的强化联合使用在维持长期阿片类药物戒断方面是有效的，这种基于就业的成瘾药物治疗模式可以被纳入社区工作场所，以传播Vivitrol（R）的有效使用;它可以被用来提高其他新的拮抗剂样成瘾药物的效用;它可以提供一种有效的手段，减少那些坚持注射海洛因的人的注射毒品使用，并使自己和他人因持续注射毒品使用和危险注射行为而面临获得或传播艾滋病毒感染的风险。

DESCRIPTION (provided by applicant): Injection heroin use is a chronic problem that fuels the transmission of HIV/AIDS through risky injection behaviors. Methadone and buprenorphine can reduce heroin use and risky injection behavior; however, they have abuse potential, produce physical dependence, can produce lethal overdose, are highly regulated, and some patients simply do not want agonist treatment. Opiate detoxifications can serve as an alternative to agonist treatment, but many injection drug users relapse to heroin use and resume risky injection behaviors after detoxification. Vivitrol(R), an extended release formulation of naltrexone, was recently approved by the FDA for the treatment of opioid dependence, but its clinical utility is uncertain given the reluctance of many opioid- dependent adults to maintain its long-term use, and the fact that some patients continue to use opiates while under naltrexone blockade. Our research in the first period of this grant showed that employment-based reinforcement can be highly effective in promoting long-term adherence to Vivitrol(R). Employment-based reinforcement may be ideally suited to address the limitations of extended release naltrexone by capitalizing on its potential to simultaneously reinforce naltrexone adherence and opiate abstinence. This grant will evaluate the effectiveness of employment-based reinforcement to simultaneously promote high rates of Vivitrol(R) adherence and increase opiate abstinence. In this 5-year study, we propose to evaluate the separate and combined effects of the FDA-approved formulation of extended release naltrexone (Vivitrol(R)) and employment- based reinforcement of opiate abstinence in promoting opiate abstinence and reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug users. After an opioid detoxification and induction onto oral naltrexone, participants will be invited to attend the Therapeutic Workplace for 24 weeks (where they can work and earn wages) and will be randomly assigned to one of four groups that will differ in whether they receive Vivitrol(R), employment-based opiate abstinence reinforcement, both or neither. Participants in Vivitrol(R) conditions will be required take scheduled injections to work and earn wages. Participants exposed to opiate abstinence reinforcement will receive a temporary decrease in their workplace pay if they fail to provide an opiate-free urine sample. The study will assess the effects of the interventions on weekly opiate urinalysis results, and on measures of injection drug use and cocaine use. If this study shows that the combined use of Vivitrol(R) and employment-based reinforcement of adherence and opiate abstinence is effective in maintaining long-term opiate abstinence, this model of employment-based addiction pharmacotherapy could be integrated into community workplaces to disseminate the effective use of Vivitrol(R); it could be used to enhance the utility of other new antagonist-like addiction medications; and it could provide an effective means of reducing injection drug use in individuals who persist in injecting heroin and exposing themselves and others to the risk of acquiring or transmitting HIV infection due to their continued injection drug use and risky injection behaviors.