Behavioral Processes for Smoking and Vaping Dual Use

(DUET Trial)

Overseen By Alexander W Sokolovsky, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Alcohol dependence, Illicit substance use, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how behaviors like craving and attention to smoking cues affect the use of traditional cigarettes and e-cigarettes. It aims to understand why individuals who use both products might crave and choose them differently in various situations, both in a lab and in real life. Participants will complete tasks to measure their reactions to smoking-related cues and images, including the Choice Task, Computerized Visual Dot Probe, and Cue Reactivity Task. Individuals aged 21 to 34 who regularly use both cigarettes and e-cigarettes and own a smartphone may be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on smoking behaviors and potentially influence future treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants with current alcohol dependence or certain mental health conditions, which might imply some restrictions on medication use.

What prior data suggests that this study protocol is safe?

Research shows that the treatments in this study—Choice Task, Computerized Visual Dot Probe, and Cue Reactivity Task—are generally safe and well-tolerated. These methods aim to understand behaviors related to smoking and vaping without using drugs or medical procedures.

In the Choice Task, studies indicate that while using both cigarettes and e-cigarettes can pose health risks, the task itself remains safe. It simply observes how people make choices between different options.

The Computerized Visual Dot Probe task examines attention direction and is safely used in research to assess reactions to smoking and vaping cues. No reports of harmful effects have emerged from this task.

The Cue Reactivity Task studies responses to cues, such as seeing someone smoke. Research shows that dual users may react more strongly, but the task itself is safe, involving controlled exposure to these cues without any physical risks.

Overall, these tasks are non-invasive and pose minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to understand and potentially tackle the dual use of smoking and vaping. Unlike traditional approaches that often focus solely on quitting smoking or vaping separately, this study uses tasks like the Choice Task, Computerized Visual Dot Probe, and Cue Reactivity Task to delve into the behavioral and psychological processes behind using both. These methods aim to reveal how attention and decision-making influence dual use, potentially leading to more effective, personalized interventions. By examining these underlying mechanisms, researchers hope to develop strategies that address the root causes of dual use rather than just the symptoms.

What evidence suggests that this trial's treatments could be effective for smoking and vaping dual use?

Research shows that the treatments studied in this trial, including the Choice Task, Computerized Visual Dot Probe, and Cue Reactivity Task, could enhance understanding of smoking and vaping habits. Studies have found that individuals who use both cigarettes and e-cigarettes often struggle more to quit than those who only smoke cigarettes. Specifically, the Cue Reactivity Task reveals that dual users have strong reactions to e-cigarette-related cues, potentially increasing cravings and use. The Computerized Visual Dot Probe identifies when individuals focus more on smoking and vaping images, which might be linked to cravings and use. These findings suggest that understanding these behaviors could be crucial for addressing the combined use of smoking and vaping. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young adults aged 21-34 who regularly use both electronic nicotine delivery systems (ENDS) and combustible cigarettes. Participants must have used both products on at least 6 of the past 7 days, own a smartphone, speak English at an 8th grade level or higher, and not be planning to quit smoking/vaping or travel in the next month. Pregnant individuals or those with current alcohol dependence, illicit substance use other than marijuana, psychosis, mania, or suicidal ideation are excluded.

Inclusion Criteria

You have used electronic nicotine delivery systems (ENDS) and traditional cigarettes in the past seven days.

You have to own a smartphone.

Smoking status confirmed via breath CO >= 6 ppm112 or NicAlert test of urine cotinine (level >= 3)

Exclusion Criteria

You have a current addiction to alcohol.

You currently have severe mental health issues like hearing or seeing things that aren't there, feeling overly excited, or having thoughts of harming yourself.

I have not used illegal drugs other than marijuana in the past month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Laboratory Sessions

Participants complete two laboratory sessions in a randomized order, exposed to CC or ENDS cues, complete attentional bias assessments, and choose between smoking or vaping.

2 weeks

2 visits (in-person)

Natural Environment Monitoring

Participants use a smartphone app for 28 days to report on craving, context, affect, and attentional bias, and complete daily assessments.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the main study activities.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Choice Task
• Computerized Visual Dot Probe
• Cue Reactivity Task

Trial Overview

The study examines how cues related to vaping and smoking affect cravings and attention in dual users of ENDS and combustible cigarettes. It involves lab sessions where participants react to cues from these products and complete tasks assessing their attentional bias towards them. Additionally, they will use a smartphone app for real-time monitoring over a month to track craving levels and product usage in daily life.

How Is the Trial Designed?

Group I: Study Protocol Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a pilot study of 21 nicotine-dependent daily drinkers, those who were not alcohol dependent showed lower cravings for alcohol in non-alcohol related virtual reality contexts, indicating that contextual cues can significantly influence craving responses.

Nicotine-dependent individuals experienced heightened cravings for nicotine in virtual reality environments that included smoking cues, but those cravings did not return to baseline levels after exposure, highlighting the persistent impact of these cues on craving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual reality to investigate complex and contextual cue reactivity in nicotine dependent problem drinkers. Traylor, AC., Parrish, DE., Copp, HL., et al.[2015]

Current smokers showed a significant tendency to focus longer on e-cigarette cues compared to neutral images, indicating that these cues may trigger cravings for tobacco cigarettes.

The study suggests that e-cigarette cues can influence craving and attitudes towards e-cigarettes, highlighting the need for potential regulation of e-cigarette marketing to mitigate their impact on smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do current and former cigarette smokers have an attentional bias for e-cigarette cues? Lochbuehler, K., Wileyto, EP., Tang, KZ., et al.[2022]

A study involving 46 nicotine-dependent adult smokers demonstrated the feasibility of using a virtual reality-based cue reactivity assessment (VR-NCRAS) to evaluate craving and attention to smoking cues during treatment.

The VR-NCRAS was assessed at baseline, Week 4, and Week 10, indicating that this innovative approach can provide valuable insights into craving patterns and potentially guide treatment decisions for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Using Virtual Reality to Assess Nicotine Cue Reactivity During Treatment. Kaganoff, E., Bordnick, PS., Carter, BL.[2021]

A pilot fMRI study involving 7 experienced e-cigarette users revealed that viewing e-cigarette cues significantly activated sensorimotor brain areas, indicating a strong cue-reactivity response after using e-cigarettes.

The study found that using e-cigarettes led to an increase in plasma nicotine concentration, suggesting that habitual use may enhance craving responses, although no significant activity was detected in other brain regions typically associated with craving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue-reactivity in experienced electronic cigarette users: Novel stimulus videos and a pilot fMRI study. Nichols, TT., Foulds, J., Yingst, JM., et al.[2018]

A working group identified 13 important constructs related to tobacco use and recommended 9 additional measures for the PhenX Tobacco Regulatory Research Collection, enhancing the understanding of both conventional and newer tobacco products.

The group highlighted gaps in existing measures, particularly the need for tools to assess nicotine dependence and withdrawal in adolescents and users of non-combusted tobacco products, indicating areas for future research and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PhenX: Host: Biobehavioral measures for tobacco regulatory research. Giovino, GA., Swan, GE., Blount, B., et al.[2023]

In a study of 345 young adult smokers, dual users of electronic nicotine delivery systems (ENDS) exhibited a higher desire for vaping and greater reactivity to ENDS cues compared to exclusive smokers, indicating a stronger urge to smoke after exposure to vaping cues.

Both dual users and exclusive smokers showed similar reactivity to cigarette cues, suggesting that dual users may find it challenging to quit tobacco products or transition to exclusive vaping due to their heightened responses to both types of cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems (ENDS) cue reactivity in dual users: A combined analysis. King, AC., Brett, EI., Vena, A., et al.[2022]

In a pilot trial with 13 nicotine-dependent participants, exposure to virtual reality (VR) smoking cues significantly increased craving intensity by an average of 118% compared to VR neutral cues.

This study suggests that VR cue reactivity can provide a standardized and controlled method for examining drug triggers, which may enhance research and treatment strategies for substance abuse and smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing virtual reality to standardize nicotine craving research: a pilot study. Bordnick, PS., Graap, KM., Copp, H., et al.[2015]

In a study of 36 daily smokers who had never used e-cigarettes, those with a stronger neuroaffective response to nicotine-related cues (C>P profile) were found to use e-cigarettes significantly more often than those who responded more to pleasant stimuli (P>C profile).

The findings suggest that individual differences in how people react to drug-related cues can predict their vulnerability to using e-cigarettes, indicating that personalized treatments targeting these neuroaffective profiles may enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroaffective reactivity profiles are associated with vulnerability to e-cigarette use. Versace, F., Kypriotakis, G., Pluta, D.[2023]

Restricting JUUL flavors to only tobacco significantly decreases the appeal of these products among young adult users, which could help in reducing their use.

Lowering the nicotine content of JUUL pods from 5% to 3% does not affect the product's appeal, suggesting that nicotine levels may not be a primary factor influencing young adults' preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appeal, subjective effects, and relative reinforcing effects of JUUL that vary in flavor and nicotine content. Pacek, LR., Kozink, RV., Carson, CE., et al.[2022]

Visual depictions of vaping in e-cigarette advertisements significantly increased the urge to smoke among daily smokers, leading to a higher likelihood of smoking during the experiment.

Former smokers exposed to vaping visuals reported lower intentions to abstain from smoking, indicating that these advertisements may negatively impact their efforts to stay smoke-free.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Vaping in E-Cigarette Advertisements Affect Tobacco Smoking Urge, Intentions, and Perceptions in Daily, Intermittent, and Former Smokers? Maloney, EK., Cappella, JN.[2022]

A study of 593 young adult JUUL users found that those who are dual users of both pod mod e-cigarettes and traditional cigarettes exhibit higher levels of e-cigarette dependence compared to those who only use pod mods.

Dual users also demonstrated greater demand for e-cigarettes than former smokers and non-smokers, indicating that using both products may increase addiction potential and warrant further investigation into the mechanisms behind this trend.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarette dependence and demand among pod mod users as a function of smoking status. Leavens, ELS., Smith, TT., Natale, N., et al.[2021]

In a pilot study with 26 daily tobacco smokers, using nicotine-free e-cigarettes alongside nicotine replacement therapy significantly reduced cue-induced craving for cigarettes after 2 weeks, even though withdrawal symptoms increased during this period.

One month after the intervention, participants reported a substantial decrease in overall cigarette use, with 34.8% completely abstinent and 65.2% smoking fewer than 10 cigarettes per week, indicating that this combined approach may effectively support smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Examination of Nicotine-Free Electronic Cigarette Use During Cessation From Combustible Cigarettes. Peechatka, AL., Molokotos, EK., Zegel, M., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12243584/

Volumetric choice experiment to estimate the impact of e ...

A sample of 318 adults who smoke and recently initiated/reinitiated e-cigarette use participated in an online volumetric choice experiment in ...

2.

publications.ersnet.org

publications.ersnet.org/content/erjor/11/3/00902-2024

A systematic review investigating the impact of dual use of e ...

Dual users of e-cigarettes and cigarettes are less likely to quit smoking compared to conventional cigarette smokers, and most dual users revert to ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7542643/

Validation of an E-cigarette Purchase Task in Advanced ...

We have developed two versions of a purchase task for e-cigarette use and compared the two versions in users of advanced generation e-cigarette devices.

4.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20746-9

Prevalence of dual use of combustible tobacco and E ...

This systematic review and meta-analysis aimed to determine the overall prevalence of dual use of tobacco smoking and e-cigarette use in pregnant women.

5.

link.springer.com

link.springer.com/article/10.1007/s11606-021-06615-w

a Best-Worst Discrete Choice Experiment

Recent clinical trials suggest that e-cigarettes may be more effective for smoking cessation than traditional cessation aids, yet primary ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11572542/

Prevalence of dual use of combustible tobacco and E ...

Prevalence of dual use of combustible tobacco and E-cigarettes among pregnant smokers: a systematic review and meta-analysis

7.

cdc.gov

cdc.gov/tobacco/e-cigarettes/health-effects.html

Health Effects of Vaping | Smoking and Tobacco Use

No tobacco products, including e-cigarettes, are safe. Most e-cigarettes contain nicotine, which is highly addictive and is a health danger for ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10092879/

Biomarkers of potential harm in people switching ...

Switching from smoking to vaping or dual use appears to reduce levels of biomarkers of potential harm significantly. Keywords: Electronic cigarettes ...

9.

accpjournals.onlinelibrary.wiley.com

accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/jac5.70092

Evidence Regarding E‐Cigarettes as a Harm Reduction ...

However, their relative addiction potential, lack of long-term safety data, and known or suspected cardiovascular, pulmonary, and carcinogenic ...