Human Laboratory Paradigms

The National Institutes of Health (NIH) awarded a Master IDIQ to establish a network of clinical sites conducting human laboratory paradigms to evaluate putative alcoholism therapeutics on non-treatment-seeking alcohol use disorder populations. Ordering closed on September 27, 2020 and is no longer active.

The vehicle funded applied research and protocol development across five university-based prime contractors, with all 11 task orders issued on an unrestricted, cost-no-fee basis. Brown University and Yale University each received three orders and dominate the portfolio, combining for roughly 77 percent of the $2 million combined potential value. The Medical University of South Carolina, Trustees of Indiana University, and Mind Research Network collectively hold the remaining work. Task orders ranged from $781 to $542,787 in ceiling value, with completion dates spanning 2017 through 2021. The most recent orders were issued in September 2018.

Funding originated from the National Institute of Child Health and Human Development (80 percent of orders by potential value), the National Institute on Alcohol Abuse and Alcoholism (22 percent), and the National Institute of Diabetes and Digestive and Kidney Diseases (1 percent). The vehicle obligated its full $2 million ceiling by 2018, with no new orders placed after September 2018 despite the vehicle remaining open until September 2020. Work concentrated at academic medical centers with expertise in human laboratory research and alcohol use disorder populations.

This vehicle is closed to new ordering and no longer represents a pursuit opportunity.

The National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) has a mission to develop safe and effective medications to treat alcohol use disorder (AUD) in various populations. Part of the mission involves translation of the pre-clinical findings through human laboratory studies and then ultimately to clinical trials. In order to provide this missing piece of development pipeline, human laboratory studies will be conducted with compounds and paradigms chosen by NIAAA. The NIAAA has supported both pre-clinical and clinical medications development activities and continues to further expand this research area with the addition of human laboratory paradigms. To carry out this task, NIAAA intends to develop a network of clinical sites capable of conducting multiple human laboratory paradigms on non-treatment seeking alcohol use disorder individuals that will examine the impact of putative alcoholism therapeutics on key components of the alcohol use disorder.