# CNS Effects of Alcohol: Cellular Neurobiology

> **NIH NIH P60** · SCRIPPS RESEARCH INSTITUTE, THE · 2021 · $248,500

## Abstract

Project Summary
This request is for an administrative supplement to my clinical component of AA006420, The Scripps Research
Institute's Alcohol Research Center (TSRI-ARC), for $140,000 in direct costs to offset the losses and costs
incurred due to the COVID pandemic. Any carryover funds from previous years have been expended. Impact
of the pandemic on project progress: The pandemic resulted in closure of our clinical research lab and
suspension of subject recruitment from mid-March 2020 thru mid-March 2021, making us unable to meet our
parent grant's specific aims, i.e., to evaluate the therapeutic potential of the top two drug candidates identified
by TSRI-ARC's basic scientists, using our validated human laboratory model of AUD. Work remaining on
project: We must recruit and randomize 50 subjects for each drug under study to adequately test study
hypotheses, based on power analyses in the parent grant, prior to the end date of the grant on 12/31/22. To
meet our specific aims, we have secured drug supply, INDs, and IRB approvals for the two studies as
stipulated in the parent grant: 1.) CORT118335, a selective glucocorticoid receptor (GR) antagonist, and 2.)
suvorexant, a dual orexin 1 and 2 receptor (OrxR) antagonist. Financial impact of the pandemic as it is
linked to the supplement request: The financial impact of the pandemic on my ARC component is primarily
the loss of $93,400 in salaries paid to clinical staff during lab closure from March 2020 to March 2021 while
unable to enroll subjects. We also lost advertising costs of $3,320 for subject recruitment that had been paid
going into lab closure, $3,163 paid for personal protective equipment (PPE) for staff and subjects, and incurred
the need to transfer the overnight portion of our suvorexant study from our adjoining Scripps Green Hospital
due to their inability to accommodate research subjects, given their status as a general medical hospital
and the prioritization of personnel and beds for COVID patients. We successfully negotiated to use the Altman
Clinical Translational Research Institute (ACTRI) at UCSD for the overnight stay. This incurred the following
additional covid-related costs of completing the required enrollment of 50 subjects for the suvorexant study:
$12,500 consulting fees for physician with UCSD privileges, $12,000 chaperone fees, $2,500 R/T
transportation for 50 subjects between TSRI and UCSD, and $13,117 UCSD investigational pharmacy fees.
Impact on the project if administrative supplement funds are not awarded: Taken together, each of these
two projects has a high likelihood of exerting a sustained, powerful influence on the field by translating basic
science findings into novel neuroscience-based therapeutic strategies for AUD. Importantly, there is industry
interest in moving each target forward as a treatment for AUD. If the funds are not awarded, subject
recruitment goals cannot be met, studies will be under-powered, and results will be inconclusive, with
potenti...

## Key facts

- **NIH application ID:** 10419301
- **Project number:** 3P60AA006420-38S1
- **Recipient organization:** SCRIPPS RESEARCH INSTITUTE, THE
- **Principal Investigator:** BARBARA J MASON
- **Activity code:** P60 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $248,500
- **Award type:** 3
- **Project period:** 2021-07-10 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10419301

## Citation

> US National Institutes of Health, RePORTER application 10419301, CNS Effects of Alcohol: Cellular Neurobiology (3P60AA006420-38S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10419301. Licensed CC0.

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