Department of Psychiatry, Virginia Commonwealth University, Richmond, Virginia.
Institute for Drug and Alcohol Studies, Virginia Commonwealth University, Richmond, Virginia.
Am J Addict. 2021 Jul;30(4):398-405. doi: 10.1111/ajad.13170. Epub 2021 Apr 28.
Current methods of classifying individuals with substance use disorder (SUD) result in vast heterogeneity among persons within a given diagnosis. These approaches, while clinically allowing for distinctions between patient groups, are less than ideal when attempting to recruit a neurobehaviorally defined subset of subjects into clinical trials. To address this gap, alternative strategies have been proposed, including behavioral phenotyping. The NIDA Phenotyping Assessment Battery (PhAB) is a modular package of assessments and neurocognitive tasks that was developed for use in clinical trials. The goal of the present study is to assess the feasibility of the NIDA PhAB with regard to ease of administration and time burden.
Healthy controls, persons with cocaine use disorder (CocUD), opioid use disorder (OUD), cannabis use disorder (CanUD), and combined opioid and cocaine use disorder (OCUD) were recruited from various sources (N = 595). Participants completed screening and one to three assessment visits. Time to complete the measures was recorded and a satisfaction interview was administered.
Of the participants enrolled, 381 were deemed eligible. The majority of eligible participants (83%) completed all assessments. The average completion time was 3 hours. High participant satisfaction ratings were noted, with over 90% of participants endorsing a willingness to participate in a similar study and recommend the study to others. CONCLUSION AND SCIENTIFIC SIGNIFICANCE: These findings corroborate the ease with which the PhAB may be easily incorporated into a study assessment visit without undue participant burden. The PhAB is an efficient method for behavioral phenotyping in addiction clinical trials. (Am J Addict 2021;00:00-00).
目前用于对物质使用障碍（SUD）患者进行分类的方法导致在特定诊断下的患者群体中存在巨大异质性。这些方法虽然在临床上允许对患者群体进行区分，但在试图将具有神经行为定义的亚组招募到临床试验中时并不理想。为了解决这一差距，已经提出了替代策略，包括行为表型。NIDA 表型评估电池（PhAB）是一个模块化的评估和神经认知任务包，专为临床试验而开发。本研究的目的是评估 NIDA PhAB 在管理和时间负担方面的可行性。
从各种来源招募了健康对照者、可卡因使用障碍（CocUD）患者、阿片类药物使用障碍（OUD）患者、大麻使用障碍（CanUD）患者和合并阿片类药物和可卡因使用障碍（OCUD）患者（N=595）。参与者完成了筛选和一到三次评估访问。记录完成测量的时间，并进行满意度访谈。
在所招募的参与者中，有 381 人被认为符合条件。大多数符合条件的参与者（83%）完成了所有评估。平均完成时间为 3 小时。参与者的满意度评分很高，超过 90%的参与者表示愿意参加类似的研究，并向他人推荐该研究。结论和科学意义：这些发现证实了 PhAB 可以轻松地纳入研究评估访问，而不会给参与者带来不必要的负担。PhAB 是成瘾性临床试验中行为表型的有效方法。
