Behavioral Processes for Smoking and Vaping Dual Use

(DUET Trial)

AW
Overseen ByAlexander W Sokolovsky, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Brown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.46789

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)
See 3 more

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.
See 3 more

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?
1Treatment groups
Experimental Treatment
Group I: Study ProtocolExperimental Treatment3 Interventions

Find a Clinic Near You

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

Citations

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 ...
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 ...
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.
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.
a Best-Worst Discrete Choice ExperimentRecent clinical trials suggest that e-cigarettes may be more effective for smoking cessation than traditional cessation aids, yet primary ...
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
Health Effects of Vaping | Smoking and Tobacco UseNo tobacco products, including e-cigarettes, are safe. Most e-cigarettes contain nicotine, which is highly addictive and is a health danger for ...
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 ...
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 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security