NIAAA Clinical Trials

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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. Gabapentin is a GABA analog that was originally developed to treat epilepsy (Neurontin®) and more recently has been approved for the treatment of postherpetic neuralgia (Neurontin®, Gralise®). Gabapentin enacarbil is an actively transported prodrug of gabapentin that undergoes rapid post absorption hydrolysis to gabapentin that was designed to produce dose proportional gabapentin blood level exposure. Gabapentin enacarbil Extended Release Tablets (Horizant®) is approved for the treatment of moderate to severe primary restless leg syndrome in adults and management of postherpetic neuralgia in adults. II. SCOPE The purpose of this task order is to perform the planning and preparation of study materials for the NCIG 006 study which involves conducting start-up activities, randomization and study conduct for at least 50 subjects in a randomized placebo controlled proof-of-concept clinical trial of gabapentin enacarbil for patients with alcohol use disorder.