Dual Use of ENDS and Combustible Cigarettes — DUET  

Smoking, Cigarette Clinical Trial

Official title: Dual Use of ENDS and Combustible Cigarettes: Shared, Distinct, and Cross-Conditioned Processes

Status Recruiting

Clinical Trial Summary

This study investigates the degree to which shared behavioral processes underlie combustible cigarette (CC) and electronic nicotine delivery system (ENDS) use in young adult dual users of these products in both the laboratory and natural environment. The primary processes examined by this study are cue-reactivity, attentional bias, and affect. Examining these processes in the laboratory and the real world will facilitate: a) evaluating whether behavioral processes related to use and craving in controlled settings operate in similar fashion in naturalistic settings; and b) identifying the situational factors that predict or moderate these effects. This project will enroll 80 young adults who regularly use both CC and ENDS. At the start of the study, participants will provide informed consent; biological indicators and self-report measures will be collected; and participants will become enrolled in the study. Participants will then complete two laboratory sessions in a randomized order where they will be: a) exposed to either CC or ENDS cues (based on randomized order) and report their craving for these products; b) complete a computerized attentional bias assessment; and c) choose between smoking their usual brand CC or vaping their own ENDS device over ten sequential opportunities. After the conclusion of the second laboratory session, participants will install a smartphone application that will ask participants questions 5 times per day for 28 days at random intervals assessing: craving for CC and ENDS, physical and social context, affect, and attentional bias. Using the smartphone application, participants will also: a) complete a daily computerized assessment of attentional bias abbreviated from the laboratory sessions; b) report on CC and ENDS cues they experience in the natural environment; and c) report their use of CC and ENDS. A subset of participants will complete a focus group where they will be asked about real-time interventions for smoking and vaping. Laboratory hypotheses are: (1) cue exposure will elicit craving of both CC and ENDS in the laboratory and that product-specific cues will elicit stronger craving for the affiliated products; (2) visual probe effects indicating attentional bias in the laboratory will be observed for smoking and vaping images; and (3) cross-conditioning from the first hypothesis will be associated with heaviness of use of CC and ENDS and product choice. Natural environment hypotheses are: (1) presence of tobacco-related cues in the natural environment will elicit craving and use of these products; (2) reactivity to cues, attentional bias, and cross-product conditioning assessed in the laboratory will be associated with craving and use of tobacco products over and above the effects of cues in the natural environment; and (3) negative affect will strengthen these associations.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Smoking, Cigarette

• NCT number: NCT05280535
• Study type: Interventional
• Source: Brown University
• Contact: Alexander W Sokolovsky, PhD
• Phone: 4018636629
• Email: alexander_sokolovsky@brown.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2022
• Completion date: December 31, 2024