Developing a Clinical Outcome Assessment for Opioid Craving Using Patient Feedback (DDT-COA-000138)

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This project is a continuation of our efforts to develop a clinical outcome assessment for opioid craving (DDT#00138) that can be qualified by the Food and Drug Administration (FDA) to support medication labeling. Individuals in treatment for opioid use disorder (OUD) commonly experience opioid craving, which is a persistent and troublesome symptom associated with non-prescribed opioid use and treatment discontinuation. However, existing measures for opioid craving lack validity and consensus, making it challenging to develop effective interventions for this feature of OUD. To date, we have conducted focus groups, one-on-one interviews, and cognitive interviews to develop a new craving assessment that incorporates stakeholder concept elicitation and reporter input. We now propose two projects to further advance and refine the new craving assessment, continuing to use the FDA framework for developing a qualified measure. These projects will focus on obtaining patient feedback regarding the acceptability, appropriateness, and burden of the craving assessment. The first project will involve cognitive interviews to evaluate the appropriateness of opioid craving assessment items, the optimal time frame for conducting a craving assessment, and patient preferences for questionnaire response options. Cognitive interviews will also query patterns of craving, including frequency and changes in severity, to inform the optimal time frame for assessing opioid craving. To collect data that is representative of the U.S. population, cognitive interviews will be conducted remotely, based on methods from a recently completed study, and recruitment will be based in San Francisco, CA; Seattle, WA; Houston, TX; St. Louis, MO; Atlanta, GA; Philadelphia, PA; and Boston, MA. Participants will provide a release of medical information to confirm treatment status and/or will complete urine drug toxicology testing at a commercial laboratory. The second project will involve focus group discussions based on the craving assessment refined from cognitive interview feedback. The goals of the focus groups will be to assess what other changes are needed to improve the clarity and appropriateness of assessment items and what components of the assessment creates burden for patients (e.g., length, reactivity to language related to drug use). Focus group discussions will take place in person in Baltimore, MD; Morgantown, WV; Cincinnati, OH; and Salt Lake City, UT. As part of the opioid craving assessment development, we will also convene an expert advisory committee to review and provide expert input on the proposed craving assessments after cognitive interviews and again after the focus group discussions. Expert and reporter input will be analyzed and summarized for submission in a Qualification Plan to the FDA. As part of the grant, we will also develop a quantitative analysis plan for the Qualification Plan submission, including plans for item-level descriptions, exploratory factor analyses, reliability testing, and other validity testing. The proposed steps of this grant will advance the goal to develop a qualified patient reported outcome for opioid craving to shape innovative, lifesaving treatments for opioid use disorder.