80 Participants Needed

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)

Trial Summary

What is the purpose of this trial?

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. 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. 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. 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.

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 data supports the effectiveness of the treatment Choice Task, Computerized Visual Dot Probe, Cue Reactivity Task for smoking and vaping dual use?

Research shows that cue reactivity assessments, like those used in virtual reality settings, can effectively measure and reduce cravings in smokers. Studies have demonstrated that exposure to smoking cues in controlled environments can increase cravings, but interventions like nicotine-free e-cigarettes combined with nicotine replacement therapy can help decrease these cravings over time.12345

Is the treatment for smoking and vaping dual use safe for humans?

The research articles do not provide specific safety data for the treatment methods like Choice Task, Computerized Visual Dot Probe, or Cue Reactivity Task, but they do explore related topics such as e-cigarette use and dependence, which are relevant to understanding the broader context of smoking and vaping behaviors.36789

How does the Behavioral Processes for Smoking and Vaping Dual Use treatment differ from other treatments?

This treatment is unique because it uses tasks like the Choice Task, Computerized Visual Dot Probe, and Cue Reactivity Task to understand and address the psychological and behavioral aspects of smoking and vaping. Unlike traditional treatments that might focus on medication or counseling, this approach targets the mental processes and reactions to smoking and vaping cues, which can help in reducing cravings and improving self-control.35101112

Eligibility Criteria

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)
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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.
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Timeline

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

Treatment Details

Interventions

  • Choice Task
  • Computerized Visual Dot Probe
  • Cue Reactivity Task
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Study ProtocolExperimental Treatment3 Interventions
All participants will receive all laboratory protocol components in a within-person randomized order across two sequential laboratory sessions.

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+

Findings from Research

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]
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.
Utilizing virtual reality to standardize nicotine craving research: a pilot study.Bordnick, PS., Graap, KM., Copp, H., et al.[2015]
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.
Cue-reactivity in experienced electronic cigarette users: Novel stimulus videos and a pilot fMRI study.Nichols, TT., Foulds, J., Yingst, JM., et al.[2018]

References

Feasibility of Using Virtual Reality to Assess Nicotine Cue Reactivity During Treatment. [2021]
Utilizing virtual reality to standardize nicotine craving research: a pilot study. [2015]
Cue-reactivity in experienced electronic cigarette users: Novel stimulus videos and a pilot fMRI study. [2018]
A Preliminary Examination of Nicotine-Free Electronic Cigarette Use During Cessation From Combustible Cigarettes. [2020]
Using virtual reality to investigate complex and contextual cue reactivity in nicotine dependent problem drinkers. [2015]
Neuroaffective reactivity profiles are associated with vulnerability to e-cigarette use. [2023]
PhenX: Host: Biobehavioral measures for tobacco regulatory research. [2023]
Electronic cigarette dependence and demand among pod mod users as a function of smoking status. [2021]
Appeal, subjective effects, and relative reinforcing effects of JUUL that vary in flavor and nicotine content. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Do current and former cigarette smokers have an attentional bias for e-cigarette cues? [2022]
Does Vaping in E-Cigarette Advertisements Affect Tobacco Smoking Urge, Intentions, and Perceptions in Daily, Intermittent, and Former Smokers? [2022]
Electronic nicotine delivery systems (ENDS) cue reactivity in dual users: A combined analysis. [2022]