Clinical Research Sites for the NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), operating through the National Institute of Child Health and Human Development (NICHD) Office of Acquisitions, awarded this Master IDIQ on March 15, 2021 to establish a network of clinical research sites conducting Phase I and Phase II human-subjects trials for medications development to treat alcohol use disorder, with ordering authority extending through March 14, 2028. The vehicle is unrestricted, non-set-aside, and carries a $48.0 million shared ceiling across all task orders.

Nineteen task orders have issued as of September 2025, with $4.6 million in combined potential value and $3.7 million (81% of potential value) obligated. Award velocity peaked in 2021 with 11 orders but has slowed to 8 orders annually in 2025, suggesting potential wind-down as the vehicle approaches its March 2028 expiration. Nearly 20 months of ordering authority remain.

Work comprises two functional categories: clinical trial execution for specific compounds (such as apremilast and ASP 8062) involving subject recruitment, enrollment, retention, Good Clinical Practice testing, medication administration, and data collection; and core function activities providing expert principal investigator protocol reviews, ad-hoc consultation, query resolution, and site-specific management and preparedness. Task orders use Cost No Fee pricing throughout.

Five universities hold 74% of task orders by count and 87% of combined potential value. University of California, Los Angeles leads with 4 orders worth $1.6 million combined potential value, followed by Rector & Visitors of The University of Virginia (3 orders, $931 thousand), Brown University (3 orders, $771 thousand), The University of Texas Southwestern Medical Center (2 orders, $349 thousand), and The Medical University of South Carolina (2 orders, $345 thousand). Four smaller institutions hold the remaining awards. NIAAA places all 19 orders under this vehicle, creating single-customer concentration.

Individual task-order values range from approximately $12 thousand for core function activities to $683 thousand for full clinical trial efforts, with most trial orders in the $450 thousand to $683 thousand range and core function task orders typically under $36 thousand. Most trial task orders run 1.5 to 2 years; core function orders extend to May 2028 or March 2028. The vehicle supports anticipated recruitment of 35–40 subjects per site per trial, with trials approximately 1.5 to 2 years apart.

Establish a network of multiple clinical research sites to conduct Phase II (and Phase I leading to Phase II) clinical research studies involving human subjects for the NIAAA Medications Development Clinical Investigations Network for medications development for the treatment of Alcohol Use Disorder.