DUET: Dual Use of ENDS and Combustible Cigarettes

Sponsor

Brown University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05280535

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking, Cigarette Electronic Cigarette Use	Behavioral: Cue Reactivity Task Behavioral: Computerized Visual Dot Probe Behavioral: Choice Task	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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).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)

Primary Purpose:

Basic Science

Official Title:

Dual Use of ENDS and Combustible Cigarettes: Shared, Distinct, and Cross-Conditioned Processes

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Protocol All participants will receive all laboratory protocol components in a within-person randomized order across two sequential laboratory sessions.	Behavioral: Cue Reactivity Task 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. Behavioral: Computerized Visual Dot Probe 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). Behavioral: Choice Task In the choice task, participants will choose between smoking their usual brand cigarette or their own e-cigarette over ten sequential ad-libbed trials.

Arm

Intervention/Treatment

Experimental: Study Protocol

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

Behavioral: Cue Reactivity Task

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.

Behavioral: Computerized Visual Dot Probe

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).

Behavioral: Choice Task

In the choice task, participants will choose between smoking their usual brand cigarette or their own e-cigarette over ten sequential ad-libbed trials.

Outcome Measures

Primary Outcome Measures

Change in acute craving for cigarettes before and after cue exposure (Session 1) [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) [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) [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) [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) [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) [Laboratory session 2, approximately 2 weeks after baseline]
Visual analog scale ranging from 0-100. Higher scores = more craving.
Attentional bias (objective) (Session 1) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 34 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).