# CNS Effects of Alcohol: Cellular Neurobiology

> **NIH NIH P60** · SCRIPPS RESEARCH INSTITUTE, THE · 2023 · $99,981

## Abstract

Project Summary
This request is for an administrative supplement to the Administrative Core of AA006420, The Scripps
Research Institute’s Alcohol Research Center (TSRI-ARC), for $55,238 in direct costs. The purpose of this
supplement request is to support data management, analysis, interpretation, and publication of results from the
first completed hypocretin (orexin) antagonist study in humans with alcohol use disorder (AUD). Enrollment for
this Phase 2a study was completed in Year 39 of the TSRI-ARC to meet a Specific Aim of the Clinical
Component. Covid-related overnight staffing shortages for the inpatient component of the study at a
collaborating institution necessitated extending subject enrollment through November 2022 to optimize study
sample size by the end date of the grant on 12/31/22. The extended enrollment period only permitted cursory
data entry, management, and analysis of top-line results to complete the final progress report for the grant and
the posting of topline results on clinicaltrials.gov. Comprehensive analysis of results is critical for determining
the direction of the pre-clinical hypocretin antagonist studies, including what parameters to measure in Year 40
of the TSRI-ARC Neuropharmacology Research Component, which has a primary focus on studying
hypocretin in animal models of AUD. Funding for the clinical analyses was not included in the renewal
application because there was no way to anticipate that the above circumstances would necessitate extending
the enrollment period and preclude completion of data analysis within the proposed timeframe. Furthermore,
we elected to sunset the Clinical Component in the renewal and any carryover funds from previous years have
been expended, the Center budget was cut by 10%, and our indirect cost rate increased by 4% since the
renewal was submitted. Thus, it is not possible to re-budget funds in the renewal to support the suvorexant
human laboratory data analyses without significantly negatively impacting the Specific Aims of the renewal
projects. However, part of Dr. Mason’s role as Director of the Administrative Core in Year 40 of the renewal is
to facilitate the translation of basic research, including back translation from human studies, and these clinical
data are critical to this aim. We understand it is unusual to request an administrative supplement in the first
year of a funding cycle, but it is counterproductive to wait a year while the Neuropharmacology Component
implements a research plan that may require modification based on information collected in the hypocretin
antagonist clinical proof-of-concept study. This project has a high likelihood of exerting a sustained, powerful
influence on the field by translating basic science findings into a novel neuroscience-based therapeutic
strategy for AUD. Importantly, there is industry interest in moving this target forward as a treatment for AUD. If
the requested funds are awarded, such translational goals can be met, and plan...

## Key facts

- **NIH application ID:** 10834659
- **Project number:** 3P60AA006420-40S1
- **Recipient organization:** SCRIPPS RESEARCH INSTITUTE, THE
- **Principal Investigator:** BARBARA J MASON
- **Activity code:** P60 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $99,981
- **Award type:** 3
- **Project period:** 2023-06-20 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10834659

## Citation

> US National Institutes of Health, RePORTER application 10834659, CNS Effects of Alcohol: Cellular Neurobiology (3P60AA006420-40S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10834659. Licensed CC0.

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