# Advancing VR-based attentional bias as a biomarker for tobacco use disorder

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $605,347

## Abstract

PROJECT SUMMARY
There are few effective treatment options for smoking cessation. The identification and validation of reliable
biomarkers for tobacco use disorder has the potential to greatly facilitate treatment development and improve
clinical outcomes. Attentional bias, a behavioral correlate and potential biomarker of addiction, is consistently
observed in nicotine users and is related to the risk of subsequent relapse following smoking cessation. Our
group has developed and tested a novel virtual reality (VR) nicotine cue exposure paradigm with promising
preliminary results, including obtaining large nicotine-related attentional bias effect sizes. Thus, the goal of the
proposed project is to validate the attentional bias neurophysiological marker derived from the VR Nicotine Cue
Exposure paradigm (VR-AB) as a biomarker of tobacco use disorder and investigate its potential as a predictive
marker and candidate surrogate endpoint for use in the development of novel pharmacologic interventions for
smoking cessation.
To achieve the goals of this project, 200 daily tobacco cigarette users will be assessed on the VR Nicotine Cue
Exposure paradigm then pseudo-randomized (matched on age and sex) to receive varenicline or placebo (n per
group=100). Following eight days of titration, participants will be assessed again on the VR Nicotine Cue
Exposure paradigm at target dose of varenicline (1 mg twice daily). They will then be followed via mobile
assessments for eight days on the target dose to assess short-term nicotine use behaviors. Varenicline will be
used as a pharmacological challenge to validate the VR-AB marker given this medication’s proven ability to
attenuate nicotine craving/cue salience and reinforcement.
In accordance with NIDA’s Notice of Special Interest on Biomarker and Biotypes of Drug Addiction (NOT-DA-
20-012) and the FDA’s Biomarkers, EndpointS, and other Tools (BEST) resources, the broad aims of the
proposed project are to: (1) validate the reliability of the VR attentional bias (VR-AB) marker and estimate the
VR-AB effect size as moderated by varenicline, (2) evaluate VR-AB as a predictive biomarker for response to
varenicline, and (3) evaluate VR-AB as a candidate surrogate endpoint by assessing the predictive validity of
the VR-AB biomarker on short-term nicotine use behaviors as moderated by varenicline.

## Key facts

- **NIH application ID:** 10979047
- **Project number:** 1R01DA058665-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Kelly Elizabeth Courtney
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $605,347
- **Award type:** 1
- **Project period:** 2024-08-15 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10979047

## Citation

> US National Institutes of Health, RePORTER application 10979047, Advancing VR-based attentional bias as a biomarker for tobacco use disorder (1R01DA058665-01A1). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10979047. Licensed CC0.

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