Dual Use of ENDS and Combustible Cigarettes

Smoking, Cigarette Clinical Trial

— DUET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280535
• Other study ID #: 2003002659
• Secondary ID: 1K08DA048137-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Brown University
• Contact: Alexander W Sokolovsky, PhD
• Phone: 4018636629
• Email: alexander_sokolovsky[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 34 Years

Eligibility

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).

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Smoking, Cigarette

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	Center for Alcohol and Addiction Studies	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in acute craving for cigarettes before and after cue exposure (Session 1)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 1, approximately 1 week after baseline
Primary	Change in acute craving for cigarettes before and after cue exposure (Session 2)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 2, approximately 2 weeks after baseline
Primary	Change in acute craving for e-cigarettes before and after cue exposure (Session 1)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 1, approximately 1 week after baseline
Primary	Change in acute craving for e-cigarettes before and after cue exposure (Session 2)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 2, approximately 2 weeks after baseline
Primary	Change in acute craving for bottled water before and after cue exposure (Session 1)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 1, approximately 1 weeks after baseline
Primary	Change in acute craving for bottled water before and after cue exposure (Session 2)	Visual analog scale ranging from 0-100. Higher scores = more craving.	Laboratory session 2, approximately 2 weeks after baseline
Primary	Attentional bias (objective) (Session 1)	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.	Laboratory session 1, approximately 1 week after baseline
Primary	Attentional bias (objective) (Session 2)	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.	Laboratory session 2, approximately 2 weeks after baseline
Primary	Tobacco use (choice) (Session 1)	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.	Laboratory session 1, approximately 1 week after baseline
Primary	Tobacco use (choice) (Session 2)	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.	Laboratory session 2, approximately 2 weeks after baseline