# Developing a novel human laboratory paradigm for AUD medication screening:  Modeling the ability to resist drinking and heavy drinking

> **NIH NIH R34** · YALE UNIVERSITY · 2024 · $366,406

## Abstract

ABSTRACT
 Use of human laboratory analogues of drinking behavior can provide an efficient, cost-effective mechanistic
evaluation of a medication signal on drinking, with the result of facilitating translational work in medication
development. Existing human laboratory models have yet to focus on important FDA-endpoints for alcohol use
disorder (AUD) medication approval or World Health Organization (WHO) Risk criteria for clinical trial
investigations. To this end, we are proposing to continue to develop a novel alcohol self-administration
paradigm which models both the 1) ability to resist drinking and 2) heavy drinking. To model the ‘ability to
resist’ drinking, we are proposing to adapt procedures from our successful ‘ability to resist’ smoking models
that we have been developing and utilizing for the past 18 years. Our smoking models have demonstrated
predictive validity with regards to smoking cessation medications with large effects and have been utilized
widely by the research community and the pharmaceutical industry. We are planning to develop our ‘ability to
resist’ drinking models following the staged process that we have used to develop our smoking models. For
this 2-year application, we are proposing to develop two versions of the ‘ability to resist’ drinking model
designed to screen AUD medications which map onto clinically meaningful endpoints. Model 1 will map onto
key FDA endpoints for AUD medication approval: % abstinent, and % with no heavy drinking. Model 2 will map
onto non-abstinent outcomes (i.e., WHO Risk criteria). We also plan to evaluate potential mechanisms
underlying the ability to resist drinking and ad-libitum drinking behavior across the two models. Positive
findings from this proposal will 1) provide the necessary data to proceed with validating the models using
medications with known clinical efficacy for AUD and 2) ultimately provide an important resource to the
research community that will facilitate translational work in medication development for alcohol use disorder.

## Key facts

- **NIH application ID:** 10947789
- **Project number:** 1R34AA031678-01
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Sherry Ann McKee
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $366,406
- **Award type:** 1
- **Project period:** 2024-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10947789

## Citation

> US National Institutes of Health, RePORTER application 10947789, Developing a novel human laboratory paradigm for AUD medication screening:  Modeling the ability to resist drinking and heavy drinking (1R34AA031678-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10947789. Licensed CC0.

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