Developing a Clinical Outcome Assessment for Opioid Craving

阿片类药物渴求是阿片类药物使用障碍（OUD）患者未满足的治疗需求， 复发的例子。目前还没有普遍接受和有效的评估阿片类药物的渴望。最近的一 范围审查确定了15种独特的阿片类药物渴望评估，这些评估已用于已发表的研究， 但没有一个是完全通过心理测量验证的我们收集并公布了初步数据， 表明OUD患者使用“渴望”一词来指代各种不同的， 有临床意义的渴望维度根据我们的研究结果，没有现有的评估阿片类药物的渴望， 充分评估参与者描述的多个渴望维度。这些数据表明， 需要进行研究以开发有效的阿片类药物渴求评估，以捕获所有相关的阿片类药物渴求 尺寸.开发一个有效的，FDA合格的评估将支持创造新的干预措施 治疗阿片类药物渴望并促进FDA对缓解阿片类药物渴望的治疗的标签。我们集团 最近完成了FDA资格认证过程的第一阶段;我们对阿片类药物渴望的建议 在意向书中提交了一项评估，以支持接受OUD治疗的个人，并获得批准 FDA药物评估和研究中心。FDA认证程序的第二阶段 主要侧重于为拟议的评估建立内容有效性。为了建立内容有效性， FDA要求（1）利益相关者群体关于应包括在 阿片类药物渴求的评估，以及（2）评估参与者可接受性的标准化访谈， 对阿片类药物渴求的现有评估的理解。本R21建议进行一项研究，以收集定性数据 在一个严格的实验室模型的线索诱导阿片类药物的渴望，以建立内容效度的渴望 考核参与者（n = 81）将是正在接受OUD治疗的个体。与会者将出席 三次门诊实验室会议，他们将分别暴露于（1）视觉和触觉中性 线索，（2）视觉阿片类线索，（3）视觉和触觉阿片类线索;对应于“无”、“低”和“高” 线索诱导的渴望程度在线索暴露之后，参与者将被要求描述他们自己的 他们的想法，情绪和症状，他们的经验期间和之后的线索诱导的渴望任务。 接下来，参与者将被要求完成一份简短的症状清单，并评估他们对阿片类药物的渴望程度 关于9个现有的渴望问题。参与者还将被要求提供对现有渴望的反馈 在标准化面试中进行评估。最终，这些数据将确定所经历的渴望域 在低渴望和高渴望两种情况下的相关利益相关者人群中。这项研究将直接支持 一系列有计划的系统分析，通过额外的有效性测试来评估已识别的渴望域 （标准、收敛、发散）、可靠性测试，并将评估变更能力， FDA关于建立合格临床结局评估的要求。

Opioid craving is an unmet treatment need for individuals with Opioid Use Disorder (OUD) which contributes to instances of relapse. There is no universally accepted and validated assessment for opioid craving. A recent scoping review identified 15 unique opioid craving assessments that have been used in published research, but none are fully psychometrically validated. We have collected and published preliminary data which demonstrates that persons with OUD are using the word “craving” to refer to a wide range of different and clinically-meaningful craving dimensions. According to our findings, no existing assessment of opioid craving adequately assesses the multiple craving dimensions described by participants. These data suggest more research is needed to develop a valid opioid craving assessment which captures all relevant opioid craving dimensions. Developing a valid, FDA-qualified assessment would support the creation of novel interventions to treat opioid craving and facilitate FDA labeling of a treatment for mitigating opioid craving. Our group recently completed the first stage of the FDA qualification process; our proposal for an opioid craving assessment to support individuals receiving treatment for OUD was submitted in a letter of intent and approved by the FDA Center for Drug Evaluation and Research. The second stage of the FDA qualification process primarily focuses on establishing content validity for the proposed assessment. To establish content validity, the FDA requires (1) qualitative feedback from stakeholder populations about what should be included in an assessment of opioid craving, and (2) standardized interviews which evaluate participant’s acceptability and comprehension of existing assessments of opioid craving. This R21 proposes a study to collect qualitative data in a rigorous laboratory model of cue-induced opioid craving to establish content validity for a craving assessment. Participants (n = 81) will be individuals who are in treatment for OUD. Participants will attend three outpatient laboratory sessions where they will be separately exposed to (1) visual and tactile neutral cues, (2) visual opioid cues, and (3) visual and tactile opioid cues; corresponding to “no”, “low”, and “high” levels of cue-induced craving. Following cue exposure, participants will be asked to describe in their own words the thoughts, moods, and symptoms they experience during and after the cue-induced craving task. Next, participants will be asked to complete a brief symptom checklist and rate their level of craving for opioids on 9 existing craving questions. Participants will also be asked to provide feedback on existing craving assessments in a standardized interview. Ultimately, these data will identify craving domains experienced across relevant stakeholder populations during both low and high craving bouts. This study will directly support a series of planned systematic analyses to evaluate the identified craving domains via additional validity testing (criterion, convergent, divergent), reliability testing, and will be assessed for ability to change, consistent with the FDA requirements for establishing a Qualified Clinical Outcome Assessment.