Sunday, June 29, 2025 6/29/2025

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

Award Number: R01DA058665
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2028

Group Awards By:

View Award Description

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $556,149 )
2025	2025	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	2	6/11/2025	NON-COMPETING CONTINUATION	$556,149
														Subtotal = $556,149

Issue Date FY: 2024 ( Subtotal = $605,347 )
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	1	8/8/2024	NEW	$605,347
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Drug Use and Addiction Research Programs	001	1	9/4/2024	NEW	$0
														Subtotal = $605,347

Grand Total All Awards = $1,161,496

Top

All Categories

About

Search

Reports

Data Submission

Award Information

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

Award Number: R01DA058665

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2028

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer