A Critical Review of Alcohol Administration Guidelines in Laboratory Medication Screening Research: Is It Time to Include Treatment Seekers?
A Critical Review of Alcohol Administration Guidelines in Laboratory Medication Screening Research: Is It Time to Include Treatment Seekers?
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对实验室药物筛选研究中酒精管理指南的严格审查：是时候纳入治疗寻求者了吗？
DOI：
10.1111/acer.14514
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发表时间：
2021-01
期刊：
影响因子：
--
通讯作者：
McKee SA
中科院分区：
文献类型：
--
作者：
Roberts W;Verplaetse TL;Ramchandani VA;McKee SA
人类实验室研究在酒精使用障碍（AUD）药物开发中发挥着重要作用。在人体实验室筛选中发现安全有效的药物将转移到患者人群中更昂贵的临床试验中。鉴于人体实验室研究在药物开发管道中的把关作用，这些研究准确预测药物治疗在真实临床条件下的表现至关重要。另一方面，这些研究的设计也必须遵守伦理准则：临床现实的某些方面不能纳入筛选研究，因为这样做可能会使参与者面临伤害风险或违反其他伦理准则。存在着指导解决这些相互冲突的理想的公约。这篇文章考虑了招募非寻求治疗的重度饮酒者参加实验室筛选研究的做法。按照惯例，如果志愿者被认为是“寻求治疗”，即他们最近停止饮酒或有动机这样做，他们将被排除在涉及酒精管理的实验室筛选研究之外。尽管这种常见的做法可能会降低参与者的风险，但研究结果可能无法准确预测药物对寻求治疗者的影响。事实上，有经验证据表明，寻求治疗者与非寻求治疗者在他们对药物的反应方面不同（Ray等人，2017年）。在这里，我们认为招募治疗寻求者这项研究的重要性，由于他们的质的差异从nontreatment寻求者。我们认为，这些人应该是人类实验室药物筛选研究的默认人群。最后，我们讨论了由我们的研究小组领导的药物实验的两个案例，这些实验涉及向寻求治疗者施用药物。
Human laboratory studies play an important role in alcohol use disorder (AUD) medication development. Medications that are found to be safe and effective during human laboratory screening will then move to more expensive clinical trials in patient populations. Given the gatekeeping role of human laboratory studies in the medication development pipeline, it is critical that these studies accurately forecast how pharmacotherapies will perform under true-to-life clinical conditions. On the other hand, the design of these studies also must adhere to ethical guidelines: certain aspects of clinical reality cannot be incorporated into screening studies because doing so might place the participant at risk for harm or breach other ethical guidelines. Conventions exist that guide the resolution of these conflicting ideals. This article considers the practice of recruiting nontreatment-seeking heavy drinkers to participate in laboratory screening studies. By convention, volunteers are excluded from laboratory screening studies that involve alcohol administration if they are deemed “treatment seeking,” meaning that they recently stopped drinking or are motivated to do so. Although this common practice may reduce risk to participants, findings may not accurately predict medication effects on treatment seekers. Indeed, there is empirical evidence that treatment seekers differ from non-treatment seekers in their responses to medications (Ray et al., 2017). Here, we argue for the importance of recruiting treatment seekers for this research due to their qualitative difference from nontreatment seekers. We argue that these individuals should be the default population in human laboratory medication screening studies. We conclude by discussing 2 case examples of medication experiments led by our research groups that involved administering medications to treatment seekers.
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DOI：
10.15288/jsa.2000.61.220
发表时间：
2000-03-01
期刊：
JOURNAL OF STUDIES ON ALCOHOL
影响因子：
--
作者：
Drobes, DJ;Anton, RF
通讯作者：
Anton, RF
影响因子：
3.4
作者：
Covault, Jonathan;Pond, Timothy;Feinn, Richard;Arias, Albert J.;Oncken, Cheryl;Kranzler, Henry R.
通讯作者：
Kranzler, Henry R.
影响因子：
2.2
作者：
Foddy, B;Savulescu, J
通讯作者：
Savulescu, J
影响因子：
3.7
作者：
Bacio, Guadalupe A.;Lunny, Katy F.;Ray, Lara A.
通讯作者：
Ray, Lara A.
DOI：
10.1016/s0899-3289(96)90260-6
发表时间：
1996-01-01
期刊：
JOURNAL OF SUBSTANCE ABUSE
影响因子：
--
作者：
Dawson, DA
通讯作者：
Dawson, DA