Clinical Neurobehavioral Center (CNC)
The Clinical Neurobehavioral Center (CNC) is dedicated to conducting research combining neuroscientific, behavioral-pharmacological, and clinical-psychological methods into an integrated program of human laboratory and clinical outpatient research and treatment studies, which are designed to identify new medications that are effective for the treatment of various subpopulations of drug-addicted individuals. Directed by The Dr. Irving J. Taylor Professor and Chair, Bankole Johnson, DSc, MD, the Center houses state-of-the-art equipment and space that allow investigators to simultaneously conduct numerous clinical trials, ultimately maximizing efficiency and cost-effectiveness. The Center has a portfolio of projects with funding from the National Institute of Alcohol Abuse and Alcoholism (NIAAA) and other competitive funding agencies.
The Clinical Neurobehavioral Center (CNC) is located in Howard County, just south of the main University of Maryland School of Medicine (UMSOM) campus.
CURRENT RESEARCH STUDIES
Minocycline for Alcohol Use Disorder
(Daniel Roche, PI).
The research objective of this project is to advance medication development for AUD by conducting a randomized, double blind, placebo-controlled, neuroimaging study to examine the effects of minocycline on neuroinflammation, alcohol cue reactivity, neurocognitive performance, and alcohol use. In the proposed study, non-treatment seeking individuals with a current DSM-5 AUD diagnosis (N = 32) will be randomized to receive either 200 mg of minocycline per day or placebo for 28 days and complete two laboratory sessions. The first laboratory session will be performed immediately before commencing the medication regimen (day 0) and the second will be completed after taking the medication daily for 28 days. Within each laboratory session, participants will complete a cue reactivity paradigm, neurocognitive performance tasks, and a positron emission tomography (PET) imaging session. Neuroinflammation will be assessed by using PET imaging with the radiotracer N-(2,5-dimethoxy-benzyl)-N-(5-fluoro-2-phenoxyphenyl) acetamide, labeled with carbon-11 ([11C]-DAA1106), which binds to the mitochondrial translocator protein, a marker of activated microglia in brain. Additionally, blood samples will be drawn on days 0, 7, 14, 21, and 28 to measure circulating levels of proinflammatory markers and alcohol use over the four weeks of treatment will also be measured.
Genomic Predictors of Placebo response in Phase II AUD Trials
(Chamindi Seneviratne, PI).
This study will utilize existing comprehensive data and samples from past NIAAA-funded randomized controlled trials to generate new genome-wide data currently not available from either out-patient or laboratory-based settings. Six of the eight trials are completed and two are ongoing. By using a large cohort (N >1000) of treatment seeking individuals with AUD, we will identify gene expression patterns associated with abstinence from drinking, measured as an outcome of placebo treatment. We will correlate variable expression levels with the DNA sequence variations of these genes to identify genetic variants (genotypes) that interact with drinking patterns to influence expression of the genes. This backward approach is statistically powerful and biologically informative for identifying genetic associations in modest sample sizes. Additionally, we will explore the applicability of the identified genotype-expression biomarkers to predict treatment response in (1) placebo treated populations with comorbid conditions and, (2) AUD individuals treated with an active drug.
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase 2 Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder
(David Gorelick, PI)
This 20-week research study is being conducted to learn whether a medication called ondansetron, combined with brief counseling, is more helpful than placebo (a harmless, inactive substance) in reducing the number of heavy drinking days in people with an alcohol use disorder (AUD) who want to reduce or stop their drinking, and who also have specific genetic characteristics (also called genotypes).
A genotype reflects an individual’s DNA and influences outward appearances, like eye color, which is genetically inherited from a set of parents. We can learn about the genotype by extracting DNA from the blood and testing it. An earlier study showed that, in people with certain genotypes, ondansetron was more helpful than placebo in reducing drinking. In this study, we will use each participant’s genotype to determine whether it helps to determine a response to the study medication, and we will examine a spectrum of genes thought to be involved in the effects of ondansetron.
Biomarkers to Measure Treatment Response for Alcohol Dependence
(Chamindi Seneviratne, PI)
In a series of earlier research studies, investigators reported a genomic biomarker that correlated with amounts of recent drinking in people with alcohol-related problems, and who carry a certain genetic variation. The primary objective of this research study is to further validate the genomic biomarker to explore its potential as a test that can objectively and retrospectively predict amounts of recent heavy drinking. The secondary objective is to explore other novel molecular biomarkers of heavy drinking present in blood. All participants are required to be heavy social drinkers of European descent (without chronic health conditions) and between ages of 21 and 65 years. All genders are welcome.
Pharmacogenetic Treatment with Anti-Glutaminergic Agents for Comorbid PTSD & AUD
(Bankole Johnson and Melanie Bennett, co-PIs)
The primary objective of this 14-week research study is to determine the efficacy of a medication called pregabalin, administered orally for a period of 12 weeks, in reducing heavy drinking and symptoms of PTSD among individuals who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The secondary objective is to assess the safety and tolerability of pregabalin in participants with alcohol use disorder (AUD) and co-occurring PTSD. The investigators will utilize a large and diverse sample of African-American study participants that includes both genders and individuals with different types of trauma.
To learn more about the Clinical Neurobehavioral Center or the studies taking place there, please call (667) 214-2111.