National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA supports human subject research and clinical trials through grants, contracts, and the NIAAA Intramural Research Program. Policies and guidance established by the US Food and Drug Administration (FDA), NIH, and NIAAA should be reviewed by researchers prior to applying for support or initiating studies involving human subjects research or clinical trials. The below policies and links to outside resources...

Wednesday, April 17, 2024, 8:00 am EDT to Thursday, April 18, 2024, 12:00 pm EDT

A workshop sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Description This large, multisite clinical trial evaluated the efficacy and safety of gabapentin enacarbil extended-release (GE-XR) (HORIZANT®), a gabapentin prodrug formulation for the treatment of alcohol use disorder (AUD). Study Details Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG) NCT #: 02252536 Phase: Phase 2 Treatment Arms: Horizant® (gabapentin enacarbil) 600mg twice a day and...

Data Access Policy, Application and Agreement Description The National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III) was sponsored, designed and directed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Study Details Sponsor: The National Institute on Alcohol Abuse and Alcoholism NCT #: 01273220 Study Type: Observational Number of Participants: 36,309 Population: A cross-sectional, nationally representative sample of...

Data Access Policy, Application and Agreement NIAAA Protocol NCIG 002: A Multisite Double-Blind, Placebo-Controlled Trial of Levetiracetam Extended-Release in Very Heavy-Drinking Alcohol-Dependent Patients Description This multisite clinical trial evaluated the efficacy and safety of levetiracetam XR, for the treatment of alcohol use disorder (AUD). Study Details Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG) NCT #...

Data Access Policy, Application and Agreement NIAAA Protocol NCIG 003: A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence Description This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of varenicline tartrate for the treatment of alcohol use disorder (AUD). Study Details Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s...

Data Access Policy, Application and Agreement NIAAA Protocol NCIG 001: A Multisite Double-Blind, Placebo-Controlled Trial of Quetiapine Fumarate XR in Very Heavy-Drinking Alcohol-Dependent Patients Description  This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of quetiapine, for the treatment of alcohol use disorder (AUD).   Study Details  Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG) ...

Description The COMBINE Study is the largest pharmacotherapy trial conducted for Alcohol Use Disorder in the United States. This clinical trial evaluated the efficacy of naltrexone and acamprosate, both alone and in combination, in the context of medical management with and without Combined Behavioral Intervention (CBI). Study Details Sponsor: The National Institute on Alcohol Abuse and Alcoholism NCT #: 00006206...

Alcohol screening, brief intervention, and referral to treatment (SBIRT) resources

Of the 98,457 liver disease deaths among people ages 12 and older in 2022, 46.0% involved alcohol. Among males, 60,412 liver disease deaths occurred, with 48.6% involving alcohol. Among females, 38,063 liver disease deaths occurred, with 41.8% involving alcohol. 1 Among all cirrhosis deaths in 2019, 50.3% were alcohol related. The percentage of alcohol-associated cirrhosis deaths was highest (at 80.9%)...

De las 98,457 muertes por enfermedad del hígado entre personas de 12 años y más en 2022, el 46.0% involucró al alcohol. Entre los hombres, ocurrieron 60,412 muertes por enfermedad del hígado, con el 48.6% relacionadas con el alcohol. Entre las mujeres, ocurrieron 38,063 muertes por enfermedad del hígado, con el 41.8% relacionadas con el alcohol. 1 Entre todas las...

The Division of Epidemiology and Prevention Research (DEPR) promotes and supports applied, translational, and methodological research on the epidemiology and prevention of hazardous alcohol consumption and related behaviors, alcohol use disorder, alcohol-related mortality and morbidity, and other alcohol-related problems and consequences. DEPR advances its mission by: identifying scientific opportunities and gaps in current knowledge; setting research priorities; stimulating and supporting...

Target Audience The NIAAA Core Resource on Alcohol CME/CE activities provide CME/CE credit for healthcare professionals including physicians, physician assistants, nurses, pharmacists, and psychologists, as well as other healthcare professionals whose licensing boards accept APA or AMA credits. Others may earn a certificate of completion. Joint Accreditation Statement In support of improving patient care, CME/CE activities offered have been planned...