Key Dates

Related Announcements

None

Issued by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

Purpose

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 NIAAA’s 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 medication’s stakeholders. APEP trials are generally completed within 1.5 years and are conducted under Good Clinical Practice (GCP). 

Requirements

Please download and complete this LOI form which requests the following information:

• Intellectual Property—Indicate ownership of intellectual property pertaining to the compound. If the compound is generic or no intellectual property currently exists, please give prior development background including past intellectual property held.
• Drug Development Plan—Provide a concise plan for development of the compound from current status through commercialization.
• Preclinical Efficacy and Safety—Provide evidence-based research demonstrating compound efficacy and safety in designated animal screening models that are representative of the intended human use.
• Investigational New Drug (IND)—Provide status of IND and any studies needed to satisfy IND requirements. If applicable, include Food and Drug Administration (FDA) responses to submission of an IND package.
• Phase 1 Clinical Pharmacology (if available)—A compound may be considered for a phase 2 clinical trial upon the completion and description of necessary phase 1 human studies evaluating the compound’s dose, safety, pharmacokinetic/pharmacodynamic activity, potential drug-drug interactions, effect of food upon drug absorption, and interaction with alcohol. APEP can conduct an alcohol interaction study if all the other phase 1 requirements are completed.

For novel compounds, inclusion of an Investigator’s Brochure is strongly recommended. If the LOI contains confidential information, please contact [email protected] 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 ([email protected]) no later than September 15th, 2023.

Eligibility

Domestic and foreign, academic, government, for-profit, and non-profit institutions may submit a LOI.

Review

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). 

Inquiries

Please direct all inquiries to:

Daniel Falk, Ph.D.
Medications Development Branch
Division of Treatment and Recovery
National Institute on Alcohol Abuse and Alcoholism(NIAAA)
Telephone: 301-443-0788
Email: [email protected]