Validation of a survey tool to evaluate patient-reported outcomes for new medications to treat methamphetamine use disorder: The PROMT Survey - PROJECT SUMMARY Methamphetamine use is increasing rapidly across the country, paralleled closely by severe addiction- and health-related outcomes. Behavioral treatment interventions for methamphetamine use disorder (MUD) are available, but treatment utilization is low and dropout is high. While medication treatment for opioid use disorder has made substantial progress, there is currently no approved medication treatment for MUD. A high-affinity methamphetamine antibody medication (IXT-m200) is in development for treatment of MUD, with a Phase III clinical trial planned for the near future. Given that abstinence is extremely difficult for these patients, patient-reported outcomes (PRO) must be considered alongside conventional clinical metrics such as reported drug use and urine drug screens. Defining endpoints for use in future treatment studies that assess improvement in functioning beyond abstinence, as has been done with opioids, would create opportunities for new medicines to be evaluated and approved that might not be otherwise. Both NIDA and the FDA have expressed support for a broad range of practicable endpoints for treatment medication drug trials. Evaluating new medications using PRO may also spur development of new products that address a fuller range of the symptoms of addiction. No validated instrument exists to assess PRO outcomes for new methamphetamine-specific therapies. Better understanding such endpoints may inform the development of more tailored treatment interventions for a population historically hard to reach and unlikely to initiate or complete treatment. The proposed study will develop and validate a PRO survey intended for use in evaluations of medications to treat MUD (PROMT, Patient-Reported Outcomes for Methamphetamine Treatment). We will develop a conceptual framework to inform a first PROMT draft, review the content of PROMT with key stakeholders and people who use methamphetamine through qualitative interviews, and evaluate the psychometric properties of the survey items through statistical analysis. Importantly, as our study population is difficult to reach and often stigmatized, we will collaborate with community partners to assist with interview and pilot survey recruitment, including the Central Arkansas Harm Reduction Project (Little Rock, Arkansas), KC CARE Health Center (Kansas City, Missouri), and CAPTUS Clinical (Dallas, Texas). A multi-partner, multi-state study design will be critical in meeting recruitment goals and will maximize the generalizability of PROMT to the US treatment population.
