Dual Use of ENDS and Combustible Cigarettes (DUET)

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

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.

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use; Smoking, Cigarette
• Intervention / Treatment: Behavioral: Cue Reactivity Task; Behavioral: Computerized Visual Dot Probe; Behavioral: Choice Task

Detailed Description

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Center for Alcohol and Addiction Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 21 to 34 (inclusive)
• English-speaking at an 8th grade level
• Any self-reported past 7-day use of both ENDS and cigarettes
• Self-identification as a regular ENDS and combustible cigarette user OR use of cigarettes and e-cigarettes on at least 6 of the past 7 days including at least 3 days of using each product;
• Smoking status confirmed via breath CO >= 6 ppm112 or NicAlert test of urine cotinine (level >= 3)
• Smartphone ownership.

Exclusion Criteria:

• Intention to quit smoking or vaping during the next 30 days
• Intention to travel during next 30 days
• Current alcohol dependence (based on MINI)
• Urine-screened or past month illicit substance use other than marijuana (amphetamine, cocaine, methamphetamine, opioids, benzodiazepines
• Pregnant (due to toxicity of tobacco products)
• Current psychosis, mania, or suicidal ideation (based on MINI).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Protocol; All participants will receive all laboratory protocol components in a within-person randomized order across two sequential laboratory sessions.

Behavioral: Cue Reactivity Task; In the cue-reactivity task, participants will be exposed to either a combustible cigarette or e-cigarette cue (within-subjects randomized order across laboratory sessions) and a neutral water bottle cue. Participants will report their craving for cigarettes and e-cigarettes.; Behavioral: Computerized Visual Dot Probe; In the computerized visual dot probe task, participants will view a series of substance (cigarette or e-cigarette by trial block) versus neutral (water bottle) image trials and then respond to a subsequent image presented behind either the neutral or substance image. Order of block presentation within the task is randomized within-subjects across study sessions (i.e., cigarette OR e-cigarette block first).; Behavioral: Choice Task; In the choice task, participants will choose between smoking their usual brand cigarette or their own e-cigarette over ten sequential ad-libbed trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in acute craving for cigarettes before and after cue exposure (Session 1)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 1, approximately 1 week after baseline
Change in acute craving for cigarettes before and after cue exposure (Session 2)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 2, approximately 2 weeks after baseline
Change in acute craving for e-cigarettes before and after cue exposure (Session 1)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 1, approximately 1 week after baseline
Change in acute craving for e-cigarettes before and after cue exposure (Session 2)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 2, approximately 2 weeks after baseline
Change in acute craving for bottled water before and after cue exposure (Session 1)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 1, approximately 1 weeks after baseline
Change in acute craving for bottled water before and after cue exposure (Session 2)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 2, approximately 2 weeks after baseline
Attentional bias (objective) (Session 1)	Mean difference between reaction time of correct responses to visual stimuli presented behind substance-related versus neutral cue. Computed for both cigarettes and e-cigarettes.	Laboratory session 1, approximately 1 week after baseline
Attentional bias (objective) (Session 2)	Mean difference between reaction time of correct responses to visual stimuli presented behind substance-related versus neutral cue. Computed for both cigarettes and e-cigarettes.	Laboratory session 2, approximately 2 weeks after baseline
Tobacco use (choice) (Session 1)	Categorical choice between taking a puff of usual brand cigarette, puff from personal ENDS device, or abstaining from either cigarette or ENDS device over ten trials in ad-libbed session lasting 30 minutes. Indexed as any use of product, proportion of trials where product is use, difference between number of trials where each product was used.	Laboratory session 1, approximately 1 week after baseline
Tobacco use (choice) (Session 2)	Categorical choice between taking a puff of usual brand cigarette, puff from personal ENDS device, or abstaining from either cigarette or ENDS device over ten trials in ad-libbed session lasting 30 minutes. Indexed as any use of product, proportion of trials where product is use, difference between number of trials where each product was used.	Laboratory session 2, approximately 2 weeks after baseline

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: craving; smoking; ENDS; e-cigarette; vaping; cigarette; cue reactivity; attentional bias; negative affect; electronic nicotine delivery system
• Additional Relevant MeSH Terms: Behavior; Tobacco Smoking; Tobacco Use; Smoking; Vaping; Cigarette Smoking
• Other Study ID Numbers: 2003002659; 1K08DA048137-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified study data except for transcriptions of focus groups will be made available after the completion of all study activities.
• IPD Sharing Time Frame: After closing the study IRB protocol and destroying all identifiers. Anticipated 2 years after completion of primary data collection. Data availability will be perpetual. Additional data dissemination plans are pending.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No