July 26, 2023
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The National Institute of Alcohol Abuse and Alcoholism (NIAAA) is seeking letters of interest (LOIs) for promising medications (both novel compounds and repurposed medications) to evaluate their efficacy and safety in Phase 1 and 2 clinical trials for the treatment of alcohol use disorder (AUD). Clinical trials will be supported by a NIAAA contract and conducted by NIAAAs Alcohol Pharmacotherapy Evaluation Program (APEP). This program includes studies conducted by the NIAAA Clinical Investigations Group (NCIG), Human Laboratory Program (HLAB), and Alcohol Interaction program (ALC InX). Studies supported under this mechanism are designed by the APEP team and utilize established paradigms and protocols developed in collaboration with the medications stakeholders. APEP trials are generally completed within 1.5 years and are conducted under Good Clinical Practice (GCP).
Please download and complete this LOI form which requests the following information:
For novel compounds, inclusion of an Investigators Brochure is strongly recommended. If the LOI contains confidential information, please contact email@example.com for a non-disclosure agreement and instructions on how to securely email the LOI prior to submission.
The LOI must be emailed to Dr. Daniel Falk (firstname.lastname@example.org) no later than September 15th, 2023.
Domestic and foreign, academic, government, for-profit, and non-profit institutions may submit a LOI.
NIAAA will convene an external scientific review panel to evaluate the LOIs and recommend promising medications for inclusion in APEP. Once final selection(s) have been made, NIAAA will follow-up with LOI investigators to discuss next steps. NIAAA will select up to three medications to evaluate in the next APEP trial(s) (anticipated start Winter 2023/Spring 2024).
Daniel Falk, Ph.D.
Medications Development Branch
Division of Treatment and Recovery
National Institute on Alcohol Abuse and Alcoholism(NIAAA)