# A NOVEL HUMAN LABORATORY MODEL FOR SCREENING MEDICATIONS FOR ALCOHOL USE DISORDER

> **NIH NIH R21** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $83,641

## Abstract

Project Summary of Parent Grant: A Novel Human Laboratory Model for Screening Medications for
 Alcohol Use Disorder (R21AA027180)
 While developing novel medications to treat AUD remains a high research priority area, there are major
opportunities to refine the process of screening novel compounds. To that end, a key question in clinical
studies of novel compounds for AUD, is how to efficiently determine whether a novel medication has sufficient
evidence of initial efficacy to warrant the conduct of subsequent clinical trials. The process of screening novel
compounds for initial efficacy, known as the early phase 2 of medications development, often consists of
human laboratory studies assessing constructs of putative clinical relevance, such as alcohol craving,
subjective response to alcohol, and alcohol self-administration under laboratory conditions. Nevertheless,
these controlled human laboratory models lack the ecological validity of clinical trials in which medication
effects are established via clinically meaningful endpoints in individuals motivated to change their drinking. The
scientific premise of the proposal is that screening novel AUD medications can be efficient and clinically
meaningful if early phase 2 studies combine the internal validity of experimental laboratory testing with the
external validity of clinical trials. To that end, we propose to conduct a novel early efficacy detection paradigm
informed by the smoking cessation medication development literature, to screen both an established
(naltrexone) and a promising (varenicline) AUD medication. Specifically, this novel human laboratory protocol
involves a randomized, double-blind, placebo-controlled, 3-arm parallel group design, in which individuals with
current AUD reporting intrinsic motivation to change their drinking complete a week-long “practice quit attempt”
and cue-reactivity paradigm. The primary outcome is the number of abstinent days during the practice quit
week under active medication compared to placebo. The proposed laboratory protocol has been developed
and validated for screening smoking cessation pharmacotherapies. The objective of this protocol is to adapt
and validate this novel approach to screen pharmacotherapies for AUD.

## Key facts

- **NIH application ID:** 10095672
- **Project number:** 3R21AA027180-02S1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** LARA A. RAY
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $83,641
- **Award type:** 3
- **Project period:** 2019-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10095672

## Citation

> US National Institutes of Health, RePORTER application 10095672, A NOVEL HUMAN LABORATORY MODEL FOR SCREENING MEDICATIONS FOR ALCOHOL USE DISORDER (3R21AA027180-02S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10095672. Licensed CC0.

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