Employment-based Depot Naltrexone Clinical Trial

描述(申请人提供)：注射海洛因是一个慢性问题，通过危险的注射行为助长艾滋病毒/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，它们有滥用潜力，产生身体依赖，可以产生致命的过量，受到严格的监管，一些患者根本不想要激动剂治疗。阿片类药物戒毒可作为激动剂治疗的替代方案，但许多注射吸毒者重新吸食海洛因，并在戒毒后恢复危险的注射行为。Vivitrol(R)是纳曲酮的缓释制剂，最近被FDA批准用于治疗阿片依赖，但由于许多阿片依赖成年人不愿维持其临床疗效，其临床应用尚不确定。 长期使用，以及一些患者在纳曲酮阻断下继续使用阿片类药物的事实。我们在这笔赠款的第一阶段进行的研究表明，以就业为基础的强化可以非常有效地促进长期遵守Vivitrol(R)。基于就业的强化可能非常适合于解决纳曲酮缓释剂的局限性，因为它利用了纳曲酮同时加强纳曲酮依从性和阿片类药物戒断的潜力。这笔赠款将评估以就业为基础的强化措施的有效性，以同时促进Vivitrol(R)的高依从率和增加阿片类药物的戒断率。在这项为期5年的研究中，我们建议评估FDA批准的纳曲酮缓释剂(Vivitrol(R))配方和基于就业的阿片类药物戒断在促进阿片类药物戒断和减少最近戒毒的阿片类药物依赖注射吸毒者危险注射行为方面的单独和联合效果。在阿片类药物戒毒和口服纳曲酮诱导后，参与者将被邀请参加为期24周的治疗工作场所(在那里他们可以工作并赚取工资)，并将被随机分配到四组中的一组，这四组在他们是否接受Vivitrol(R)、基于就业的阿片戒断强化、两者都接受或两者都不接受方面将有所不同。符合Vivitrol(R)条件的参与者将被要求按计划接受注射以工作和赚取工资。如果参与者未能提供不含阿片剂的尿样，接受阿片戒断强化的参与者将暂时减少工作场所的工资。这项研究将评估干预措施对每周阿片类药物尿液分析结果的影响，以及对注射吸毒和可卡因使用措施的影响。如果这项研究表明，联合使用Vivitrol(R)和以工作为基础的坚持和阿片类药物戒断在保持长期阿片类药物戒断方面是有效的，那么这种以工作为基础的成瘾药物治疗模式可以被整合到社区工作场所，以推广Vivitrol(R)的有效使用；它可以用于提高其他新的拮抗剂类成瘾药物的效用；它可以为坚持注射海洛因并使自己和其他人因持续注射毒品和危险注射行为而使自己和其他人面临感染或传播艾滋病毒感染风险的个人提供一种有效的手段。

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.