The Division of Medications Development is an extramural NIAAA Division that plans, stimulates, develops, and supports pharmacotherapy research to treat alcohol use disorder (AUD). This includes advancing promising medications through the drug development pipeline: identifying lead compounds and optimizing their structure for potency, stability, selectivity/specificity, bioavailability, testing for preclinical efficacy (e.g., alcohol animal models), completing IND requirements (pharmacokinetic evaluations, toxicology, and formulation/manufacturing), supporting phase 1 studies (pharmacokinetic evaluations, pharmacodynamics/target engagement, safety, alcohol interaction, and abuse liability), conducting human laboratory studies and clinical trials, and directing secondary analyses to improve methodology of pharmacotherapy clinical trials for the treatment of AUD. DMD is also committed to research utilizing personalized medicine to predict favorable responders (both efficacy and safety) to a specific medication, alcohol/psychiatric comorbidity, especially post-traumatic stress disorder, internal and external collaborations to advance the development of medications for AUD, and training programs to assure that adequate numbers of highly competent scientists are engaged in current and future research on medications development.

High priority division activities include:

  • development and testing of medications for the treatment of alcohol use disorders;
  • advancing personalized medicine by  discovering genetic and phenotypic subgroups who respond favorably to experimental compounds;
  • promoting alcohol pharmacotherapy research via grants for the development of novel and repurposed compounds;
  • developing new pharmacological treatments to treat patients with AUD and psychiatric comorbidity (e.g., post-traumatic stress disorder); 
  • stimulating research that develops and evaluates alcohol biosensors for the purpose of objectively measuring real-time alcohol intake;
  • developing and implementing a standardized human laboratory paradigms program for screening/testing promising medications; and
  • promoting the initial evaluation of promising new compounds in human patients via the NIAAA Investigational New Drug (IND)-enabling program.

 

Featured Funding Opportunities

Below are some of our current funding opportunity announcements. Before submitting your application, please reach out to the staff member listed under “Scientific/Research Contacts” of the announcement to learn more.

 

Extramural Programs

DMD supports several extramural clinical programs that investigate the safety and efficacy of medications for the treatment of alcohol use disorder.

NIAAA Human Laboratory Program (HLAB):

HLAB is a pilot program started in 2016 designed to screen compounds for effectiveness using alcohol human laboratory paradigms.
 

NIAAA Clinical Investigations Group (NCIG):

NCIG is a clinical trials network started in 2007 to test the safety and effectiveness of promising medications in proof-of-concept, Phase II clinical trials.

 

Frequently Asked Questions

 
• Do you think my grant will get funded?
Answer: We advise you to contact a Program Director listed either below or on a particular Funding Opportunity Announcement (FOA) to discuss your research interests before preparing your application. This will not only help determine whether your proposal is of interest to NIAAA, but will aid in the preparation of your grant application.
 
• Who should I contact within the Division about my research proposal?
Answer: Below is a list of Program Directors and their areas of research interests. The best way to contact a Program Director whose interest aligns with your own is via email. Alternatively, if you would like to speak by phone, please indicate this in an email and a Program Director will contact you soon thereafter.
 
• What is the process for applying for funding?
Answer: When submitting a grant application to NIAAA, extramural researchers can find instructions in the Funding Opportunity Announcement to which they are applying. 
See the NIAAA application process homepage for information about grant applications, the peer review process, and understanding how applications are selected for funding.

 

Our Staff

Name

Position

Focus Area

Raye Z. Litten, Ph.D.
 

Acting Division Director
 

Medications development, alcohol biomarkers, comorbidity PTSD
 

Joanne B. Fertig, Ph.D.
 

Acting Deputy Director 
 
Medications development, comorbidity smoking, IND-enabling SBIR
 

Daniel E. Falk, Ph.D.  
 

Program Director 
 
Medications development, clinical trial design, biostatistics, outcome measures
 

Megan L. Ryan, M.B.A. 
 

Clinical Program Director/Technology Development Coordinator 
 
Medications development, human subjects protection, clinical trial design, technology transfer
 
Julie Simonds
 
Program Specialist 
 
  
 

 

 

Publications
 

  1. Medications Development to Treat Alcohol Dependence: a Vision for the Next Decade. A summary laying out NIAAA’s vision (i.e., long-range goals and key objectives) for ensuring the development and delivery of new and more efficacious medications to treat AUD.
  2. Discovery, Development, and Adoption of Medications to Treat Alcohol Use Disorder: Goals for the Phases of Medications Development.  A description of the phases of medication development as they apply to AUD, and specific goals of each phase, to advance medications for the next decade. This aim of this article is to provide a guide that will aid the alcohol research community in planning, testing, and developing medications for AUD
    .
  3. Alcohol Medications Development: Advantages and Caveats of Government/Academia Collaborating with the Pharmaceutical Industry. A discussion of how collaborations-building partnerships among various stakeholders (e.g., government, academia, pharmaceutical and biotechnology companies) can expedite the medication development process for AUD.
  4. Research Opportunities for Medications to Treat Alcohol Dependence: Addressing Stakeholders' Needs. A commentary posing a number of issues (research opportunities) that must be addressed in order to advance the alcohol research field and to make medications a mainstream treatment for problematic drinking. These issues are framed from the perspective of the various stakeholders involved, including clinicians, patients, regulatory agencies, the pharmaceutical industry, and third-party payers.
  5. Heterogeneity of alcohol use disorder: understanding mechanisms to advance personalized treatment. A review of past and new approaches for characterizing various phenotypes and mechanisms underlying AUD, and an introduction to a new classification system to guide future research.
  6. Potential Medications for the Treatment of Alcohol Use Disorder: An Evaluation of the Clinical Efficacy and Safety. A review of potential (non-FDA-approved) medications being used off-label by clinicians to treat AUD.