CompletedNot Applicable

Dual Use of ENDS and Combustible Cigarettes

United States82 participantsStarted 2022-12-14

Plain-language 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.

Who can participate

Age range

21 Years – 34 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Laboratory session 1, approximately 1 week after baseline

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

Timeframe: Laboratory session 2, approximately 2 weeks after baseline

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

Timeframe: Laboratory session 1, approximately 1 week after baseline

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

Timeframe: Laboratory session 2, approximately 2 weeks after baseline

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

Timeframe: Laboratory session 1, approximately 1 weeks after baseline

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

Timeframe: Laboratory session 2, approximately 2 weeks after baseline

Trial details

NCT IDNCT05280535

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-20

View on ClinicalTrials.gov More Smoking, Cigarette trials