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Completed

NCT Number: NCT05280535

Dual Use of ENDS and Combustible Cigarettes

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.

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Key information

Conditions

Smoking, Cigarette Behavior Cigarette Smoking Electronic Cigarette Use Smoking Tobacco Smoking Tobacco Use Vaping

Age range

21 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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).

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.

Primary outcomes

  1. Change in acute craving for cigarettes before and after cue exposure (Session 1)

    Time frame: Laboratory session 1, approximately 1 week after baseline

    Visual analog scale ranging from 0-100. Higher scores = more craving.

  2. Change in acute craving for cigarettes before and after cue exposure (Session 2)

    Time frame: Laboratory session 2, approximately 2 weeks after baseline

    Visual analog scale ranging from 0-100. Higher scores = more craving.

  3. Change in acute craving for e-cigarettes before and after cue exposure (Session 1)

    Time frame: Laboratory session 1, approximately 1 week after baseline

    Visual analog scale ranging from 0-100. Higher scores = more craving.

  4. Change in acute craving for e-cigarettes before and after cue exposure (Session 2)

    Time frame: Laboratory session 2, approximately 2 weeks after baseline

    Visual analog scale ranging from 0-100. Higher scores = more craving.

  5. Change in acute craving for bottled water before and after cue exposure (Session 1)

    Time frame: Laboratory session 1, approximately 1 weeks after baseline

    Visual analog scale ranging from 0-100. Higher scores = more craving.

  6. Change in acute craving for bottled water before and after cue exposure (Session 2)

    Time frame: Laboratory session 2, approximately 2 weeks after baseline

    Visual analog scale ranging from 0-100. Higher scores = more craving.

  7. Attentional bias (objective) (Session 1)

    Time frame: Laboratory session 1, approximately 1 week after baseline

    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.

  8. Attentional bias (objective) (Session 2)

    Time frame: Laboratory session 2, approximately 2 weeks after baseline

    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.

  9. Tobacco use (choice) (Session 1)

    Time frame: Laboratory session 1, approximately 1 week after baseline

    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.

  10. Tobacco use (choice) (Session 2)

    Time frame: Laboratory session 2, approximately 2 weeks after baseline

    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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: DUET

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2022
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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