Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone. Thus, the search for new molecular targets and more efficacious drugs is critical. The creation of the NIAAA Clinical Investigations Group (NCIG) program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct Proof-of-Concept (POC) trials of promising compounds to treat alcohol dependence. To carry out this mission, a contract mechanism was authorized to fund the NCIG program, which includes a Data Coordinating Center and a network of experienced clinical trial sites. The 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 preclinical to human laboratory studies to ultimately clinical trials. In June 2012, the NCIG 004 study was initiated under contract HHSN275200900005C for the purpose of evaluating the novel compound ABT-436, a vasopresson 1B antagonist manufactured and provided to NIAAA by AbbVie under a Cooperative Research and Development Agreement (CRADA). However, the study could not be finalized and it will be transitioned and completed under this Task Order. II. SCOPE The purpose of this Task Order is to continue the tasks associated with the completion of the NCIG 004 study.
