Dual Use of ENDS and Combustible Cigarettes

NCT05280535 | Completed

• 2 other identifiers: 20030026591K08DA048137-01A1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking, Cigarette; Electronic Cigarette Use

Keywords

cigarette; e-cigarette; ENDS; electronic nicotine delivery system; smoking; vaping; attentional bias; cue reactivity; negative affect; craving

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Study Protocol

EXPERIMENTAL

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

Behavioral: Cue Reactivity Task; Behavioral: Computerized Visual Dot Probe; Behavioral: Choice Task

Interventions

Cue Reactivity Task BEHAVIORAL

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.

Study Protocol

Computerized Visual Dot Probe BEHAVIORAL

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).

Study Protocol

Choice Task BEHAVIORAL

In the choice task, participants will choose between smoking their usual brand cigarette or their own e-cigarette over ten sequential ad-libbed trials.

Study Protocol

Eligibility Criteria

• Age: 21 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Vaping; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will receive all components of this study. Participants receive laboratory sessions in a within-person randomized order. Randomization will determine whether participants receive a cigarette OR e-cigarette cue during the in-vivo cue reactivity task. Participants who receive a given cue during the first laboratory session will receive the other cue during the second session. Within each laboratory session, the presentation order of the trials within the computerized visual dot probe task will also be randomized such that participants will either receive the cigarette vs. neutral OR e-cigarette vs. neutral block first (all participants receive both blocks of trials in both sessions).

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 15, 2022
• Study Start: December 14, 2022
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.

Locations

US (1)