Smoking, CigaretteDUETNCT05280535
Dual Use of ENDS and Combustible Cigarettes
A study testing Cue Reactivity Task, Computerized Visual Dot Probe and Choice Task in people with Smoking, Cigarette and Electronic Cigarette Use, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette, Electronic Cigarette Use
- What is being tested?
- Cue Reactivity Task, Computerized Visual Dot Probe and Choice Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2022to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02903
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking, Cigarette, Electronic Cigarette Use
- Being tested
- Cue Reactivity Task, Computerized Visual Dot Probe, Choice Task
- Keywords
- cigarette, e-cigarette, ENDS, electronic nicotine delivery system, smoking, vaping, attentional bias, cue reactivity, negative affect, craving
- Medical subject headings
- Cigarette Smoking, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue Reactivity TaskBehavioural
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 ProbeBehavioural
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 TaskBehavioural
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 group | Role | What they receive |
|---|---|---|
| Study Protocol | Experimental | All participants will receive all laboratory protocol components in a within-person randomized order across two sequential laboratory sessions. Receives: Behavioral: Cue Reactivity Task; Behavioral: Computerized Visual Dot Probe; Behavioral: Choice Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute craving for cigarettes before and after cue exposure (Session 1)
Visual analog scale ranging from 0-100. Higher scores = more craving.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Laboratory session 2, approximately 2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start14 Dec 2022
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alexander Sokolovsky, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280535
- Sponsor's protocol ID
- 2003002659
- Other IDs
- 1K08DA048137-01A1
- Acronym
- DUET
- Status last verified
- Sep 2025
- First submitted
- 25 Jan 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data except for transcriptions of focus groups will be made available after the completion of all study activities.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Use of ENDS and Combustible Cigarettes: Shared, Distinct, and Cross-Conditioned Processes
- ClinicalTrials.gov ID
- NCT05280535
- Acronym / sponsor ID
- DUET / 2003002659
- Conditions
- Smoking, Cigarette, Electronic Cigarette Use
- Keywords
- cigarette, e-cigarette, ENDS, electronic nicotine delivery system, smoking, vaping, attentional bias, cue reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Study Protocol | Experimental | Behavioral: Cue Reactivity Task, Behavioral: Computerized Visual Dot Probe, Behavioral: Choice TaskAll participants will receive all laboratory protocol components in a within-person randomized order across two sequential laboratory sessions. |
Who may qualify
- Ages
- 21 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue Reactivity TaskIn 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. | Behavioural | Study Protocol |
| Computerized Visual Dot ProbeIn 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). | Behavioural | Study Protocol |
| Choice TaskIn the choice task, participants will choose between smoking their usual brand cigarette or their own e-cigarette over ten sequential ad-libbed trials. | Behavioural | Study Protocol |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified study data except for transcriptions of focus groups will be made available after the completion of all study activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue Reactivity Task, Computerized Visual Dot Probe and Choice Task in people with Smoking, Cigarette and Electronic Cigarette Use, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acute craving for cigarettes before and after cue exposure (Session 1) (time frame: Laboratory session 1, approximately 1 week after baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.