Advancing the Use of Oral Fluid to Monitor Therapeutic and Illicit Drugs in Outpatient Clinical and Field Settings

滥用药物的口腔液体检测技术一直在进步，但尿液分析仍然是最重要的。 在大多数情况下进行药物筛查的标准矩阵，包括美沙酮维持治疗和其他门诊 成瘾治疗，尽管主要的实际优势，口服液尿液标本收集。这些是 特别是隐私问题的消除（以及患者尊严的增加），对专用浴室的需求， 需要一个同性观察员（如果观察完成），没有“害羞膀胱”的影响，以及几乎消除 潜在的样本掺假，后者需要大量的有效性测试来检测尿液。最近 研究表明，通过使用现有技术（液相色谱串联质谱 通过使用质谱法（LC/MS/MS），口腔液和尿液的总检测窗口变得相似。尽管 这些优点，口服液仍然没有广泛用于美沙酮治疗，其他门诊成瘾治疗， 以及其他环境，如缓刑/假释计划，毒品法庭，安全敏感的工作场所，以及儿童 保护性服务，需要监测其客户或员工的药物使用情况。此外，还有很大的 在药物流行病学研究中使用口腔液的可能性，如家庭调查和“街头研究”， 尿检在很大程度上是不切实际的，但及时的药物监测对于早期发现和 地方和国家毒品流行情况的变化。特别是，扩大口服液药物检测将有助于 “阿片类药物危机的真实的时间监测”（总统委员会，2017年），包括更好地监测 滥用强效合成阿片类药物（例如，芬太尼、羟考酮）。 更广泛地使用口服液的一个重要障碍是缺乏比较以下结果的当代数据： 口腔液分析，尿液分析，目前的标准，为大样本配对标本提供了相同的 人与此同时。因此，本申请的具体目的是： 1.确定口腔液分析和尿液分析在检测不同主要药物方面的差异（如有） 类别和最常见的药物化合物在一组123种可能的化合物，包括最近的 “特制毒品”这项研究将比较最先进的口腔液体检测和尿液分析的结果， 全国接受美沙酮维持治疗的新患者（n = 1，000），根据区域多样性选择。 2.与标准品相比，确定仅通过LC/MS/MS进行口服液和尿液药物筛查的效用 免疫测定筛选，随后仅LC/MS/MS确认阳性。 3.确定口腔液体分析和尿液分析与近期药物自我报告相比的敏感性 在接受美沙酮治疗时获得的使用。 如果口腔液分析产生的结果至少相当于公认的标准尿液分析，则使用口腔 流体在成瘾治疗和其他设置，其中尿液分析是常用的今天，和设置 在除口腔流体之外的任何基质都不切实际的情况下（例如，大多数流行病学研究），将是高度 supported.

The technology of oral fluid testing for drugs of abuse has been advancing, but urinalysis remains the standard matrix for drug screening in most settings, including methadone maintenance and other outpatient addiction treatment, despite major practical advantages of oral fluid over urine specimen collection. These are specifically the elimination of privacy issues (and increase in patient dignity), the need for a dedicated bathroom, the need for a same-gender observer (if observation is done), no effects of “shy bladder”, and the near elimination of potential adulteration of specimens, the latter requiring numerous validity tests to detect for urine. Recent research indicates that with the use of state of art techniques (liquid chromatography with tandem mass spectrometry- LC/MS/MS), the overall window of detection has become similar for oral fluid and urine. Despite these advantages, oral fluid is still not widely used in methadone treatment, other outpatient addiction treatment, and other settings such as probation/parole programs, drug courts, safety-sensitive workplaces, and child protective services, that need to monitor the drug use of their clients or employees. In addition, there is great potential for using oral fluid in drug epidemiological studies, such as household surveys and “street studies,” where urinalysis is largely impractical, but where timely drug surveillance is critical for early detection of and changes in local and national drug epidemics. In particular, expansion of oral fluid drug testing would contribute to “real time surveillance of the opioid crisis” (President’s Commission, 2017), including better monitoring of the abuse of powerful synthetic opioids (e.g., fentanyl, oxycodone). One important barrier to the wider use of oral fluid is a paucity of contemporary data comparing the results of oral fluid analysis to urinalysis, the current standard, for large samples of paired specimens provided by the same individuals at the same time. Consequently, the specific aims of this application are: 1. Identify differences (if any) between oral fluid analysis and urinalysis in the detection of different major drug classes and the most common drug compounds within a set of 123 possible compounds, including recent “designer drugs.” The study will compare the results between state-of-the-art oral fluid testing and urinalysis for new patients admitted to methadone maintenance treatment nationally (n = 1,000), selected for regional diversity. 2. Determine the utility of oral fluid and urine drug screening by LC/MS/MS-only as compared with standard immunoassay screening followed by LC/MS/MS confirmation of positives only. 3. Determine the sensitivity of oral fluid analysis and urinalysis as compared with self-reports of recent drug use obtained at admission to methadone treatment. If oral fluid analysis yields results at least equivalent to accepted standard urinalysis, then the use of oral fluid both in addiction treatment and other settings where urinalysis is commonly used today, and settings where any matrix other than oral fluid is impractical (e.g., most epidemiological research), would be highly supported.