Integrated Phase I/II Clinical Trial Design

The contract seeks the design and protocol development for an integrated Phase I/II clinical trial to evaluate ibogaine as a potential treatment for opioid use disorder, focusing on safety, optimal dosing, and therapeutic efficacy. The effort requires a comprehensive clinical framework that seamlessly merges the objectives of Phase I, which prioritizes dose escalation and toxicity profiling, with those of Phase II, which assesses preliminary effectiveness in reducing opioid dependence and withdrawal symptoms. The protocol must adhere to rigorous scientific and regulatory standards, incorporating appropriate patient selection criteria, monitoring procedures, endpoints, and risk mitigation strategies for a substance with significant pharmacological and safety considerations. The work is being pursued as a subcontract under the Advanced Research Projects Agency for Health, part of the Department of Health and Human Services, with a NAICS code indicating research and development in the life sciences. The solicitation was posted on August 5, 2026, and responses are due by October 15, 2026. The project is situated within a broader initiative to advance novel therapeutic interventions for the opioid crisis, requiring innovative trial design that balances exploratory research with clinical feasibility. There is no specified set-aside designation or location restriction for performance, indicating flexibility in execution while emphasizing scientific merit and regulatory alignment as key evaluation criteria.