Developing a Clinical Outcome Assessment for Opioid Craving

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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.