Notice ID: 75N95024Q00453
Related Notice: 75N95024Q00453
The goal of this project is to research improved outcomes in clinical trials for substance use disorders (SUDs), including stimulant and opioid use disorders (StUD and OUD). Specifically, we aim to examine reduced use and improved function rather than total abstinence and to see whether such endpoints may improve the effect size of medications tested for StUd and OUD. This approach and the findings will provide novel and potentially impactful information for the field, which is consistent with the overall goal of our lab, and the NIDA IRP at large, to identify barriers and develop effective treatments for patients afflicted with SUD.
The objective of the proposed project is to manage and analyze harmonized datasets of StUD and OUD clinical trials to examine novel and clinically relevant outcome measures. Specifically, we aim to investigate whether changing the endpoint of clinical trials from total abstinence to reduced use may improve the effect size of some medications that have been tested in patients with SUDs. These findings will provide important information for the field and help design more efficient and clinically relevant trials in the future.
Contract staff will be responsible for pulling, organizing and cleaning the specific harmonized data. NIDA IRP will lead the development and submission of the manuscript after receiving a detailed description of the methods and results. The contractor will be completing data management and analysis for this project. We will regularly meet with the team to brainstorm about and outline the specifics of the project. The contract team will run the analyses and will send us a final report of the methods and results, which will only include aggregate data (no raw data or personally identifiable information).
The anticipated period of performance is one year: September 3, 2024 – September 2, 2025.
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