What we do
The Section on Clinical Genomics and Experimental Therapeutics (CGET) conducts pre-clinical studies and translational clinical studies with focus on genomics and epigenetics related to the pathophysiology and treatment of alcohol use disorders and addictions. The pre-clinical work focuses on identifying molecular mechanisms involved in addictions, utilizing a wide array of methods including human population genetics, genome wide genotyping approaches, next-generation DNA and RNA sequencing and epigenetic/proteomic profiling. Findings are translated into human clinical studies using molecular biomarker, pharmacogenetic, epigenetic and functional imaging genetic approaches. Clinical studies include early phase 1 / phase 2 proof-of-concept studies of experimental novel therapeutics guided by molecular biomarker profiling. One current phase 1 study aims to characterize safety, tolerability and bioeffects of a PCSK9 inhibitor called alirocumab in non-treatment seeking heavy drinkers. This study will focus on potential therapeutic effects for liver related endpoints and explores bioeffects of alirocumab with regards to potential biomarkers.
Current Protocol
000036-AA: Safety, Tolerability and Bioeffects of Alirocumab in Non-Treatment Seeking Heavy Drinkers
This research study will evaluate the safety and efficacy of the drug alirocumab on liver enzymes and liver damage in heavy drinkers.
Research participation includes 7 outpatient visits over 8 weeks. Most study visits consist of blood draws, clinical assessments, and administration of the drug (or placebo) and last approximately 2 hours. The first and last study visits include optional liver MRI, FibroScan, and doppler/ultrasound assessments and last about 4-5 hours.
The study is enrolling 21–65-year-old male and female heavy drinkers (more than 20 drinks/week). You may not be eligible if you are pregnant or breastfeeding, are currently seeking treatment for alcohol-related problems, or if you have certain serious medical conditions.
The study is conducted at the NIH Clinical Center in Bethesda, MD. There is no cost to participate and compensation up to $2640 may be provided.
To find out if you qualify, email NIAAACGETResearch@mail.nih.gov.
ClinicalTrials.gov Identifier: NCT04781322
