Validating an Opioid Craving Assessment for FDA Qualification as a Drug Development Tool

This UG3/UH3 application proposes a continuation of our work to develop an opioid craving assessment, the Faceted Opioid Research Craving Assessment for Substance use Treatment (FORCAST) as a patient-reported outcome Drug Development Tool. Currently, there are no best practices for assessing, monitoring, or treating opioid craving, making it a neglected treatment endpoint. Our team has developed a preliminary version of an opioid craving assessment (FORCAST) using the FDA guidelines for developing patient-reported outcomes to support medication labeling. The development of this measure required extensive exploration into the construct of craving, which we have done via a comprehensive literature review of existent measures, focus groups, laboratory studies, and extensive patient feedback (e.g., R21DA054952, U01FD008072; PI: Bergeria. Co-Is Ellis, Leoutsakos, Huhn, Dunn). The aims for the current grant application strategically advance the FORCAST through the FDA Drug Development Tool qualification program by aligning the study aims with the qualification program criteria. In the UG3 phase, we will validate the factor structure of the FORCAST, as well as testing for measurement invariance across sex, age, urbanicity, and education level, and the internal consistency of the measure. To achieve these aims, we will leverage an existing collaboration with (1) Trac9, a program that works with 70 substance use disorder treatment centers throughout the U.S. to monitor patient symptoms, and (2) local clinics throughout Baltimore, MD to gather FORCAST data from 1,300 individuals in treatment for OUD. Specifically, the UG3 phase will test the following aims: (1) test and validate the factor structure of the FORCAST craving measure using exploratory and confirmatory factor analysis, 2) assess measurement invariance of the FORCAST across groups based on sex, age, urbanicity, and education level, and make modifications as necessary, and (3) examine internal consistency within the entire FORCAST measure and derived factors. In the UH3 phase, we propose a multi-site, 26-week study involving monthly visits and three, two-week data bursts that utilize ecological momentary assessment (EMA). During this phase, the FORCAST will be administered at monthly visits alongside a urine drug screen (to assess criterion-related validity), a cue-induced craving paradigm (to assess convergent construct validity), and a measure of physical health (to assess divergent construct validity). Additionally, the FORCAST will be administered on the final day of the three data bursts, following intensive assessment of self-reported drug use (to assess criterion-related validity) and reports of naturalistic craving (to assess convergent construct validity). We will also test sample invariance of the measure between the UG3 and UH3 phase. Criterion validity will also be tested by examining whether the FORCAST predicts treatment attrition. This study represents an important next step in developing a psychometrically sound measure of opioid craving and has tremendous potential in advancing research on interventions with opioid craving as a treatment endpoint.