An observational study in Tobacco Use, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by University of Oklahoma · Observational
The overall aim of the current research is to understand purchasing and product choice behaviors of tobacco/nicotine users if banning the sale of fully nicotinized cigarettes were to go into effect. A sample of up to 30 current cigarette users (n=15) and dual e-cigarette and combustible cigarette users (n=15) who are willing to try an alternative nicotine-delivery device will be recruited. They will complete the screening visit, visit 1 and 2 preceded by 12 hours of nicotine/tobacco abstinent.
Participants will be provided information about the study and will provide initial consent for screening via an online screener. Written consent will be completed in person when participants are present to the laboratory. Eligible participants will include anyone over the age of 18 years and those who exclusively use combustible cigarettes or those who dual use e-cigarettes and combustible cigarettes. For the exclusive cigarette group, we will allow some e-cigarette experimentation. Participants will complete three in-lab study visits (1 screener visit and 2 study visits) separated by a standard minimum 48-hour washout period. They will be offered an Uber or other rideshare service as transportation to each study visit, however, they will not be required to use the service.
Participants will complete an in-person screening visit in which they will be rescreened according to the eligibility criteria. Their exhaled carbon monoxide (eCO) will be checked prior to their visits as well as breath alcohol and urine pregnancy (for females) test will be conducted. Participant will also complete baseline assessment measures and Balloon Analog Risk Task (BART)- computerized task measuring impulsivity. At visit 2, participants will complete a standard 10 puff bout with the three e-cigarette devices and their usual brand cigarette. During visit 3, participants will complete three concurrent choice tasks in a counter-balanced fashion.
University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
A sample of up to 30 current cigarette smokers and dual e-cigarette and cigarette users who are willing to use/try an alternative nicotine-delivery device will be recruited via advertisements/ recruitment materials (e.g., craigslist, ads on OSU, OU, and UCO campuses, OUHSC, email) and referrals. Participants will live in the Oklahoma City, OK metro area. Participants will be provided information about the study and provide initial consent for screening via an online screener.
Additional Inclusion criteria for smokers:
Additional Inclusion criteria for dual users:
Exclusion Criteria:
Additional Exclusion criteria for smokers:
Exclusive cigarette smokers must smoke at least 10 cigarettes per day for the past three months and have exhaled carbon monoxide (eCO) levels of at least 6 ppm at the screening visit.
Dual e-cigarette and cigarette users must have smoked at least 5 cigarettes per day for the last 3 months and use e-cigarettes at least 15 days per month for the last 3 months.
Nicotine delivery measured by serum (blood) nicotine
Participants will complete one standardized puffing bout (10 puffs) with each of the three electronic cigarettes and their usual brand cigarette. Serum nicotine will be measured throughout each standardized puffing bout. Greater levels of serum nicotine will be indicative of greater nicotine delivery.
Time frame: 1 month
Proportion of puffs earned and allocated to each product in three hypothetical tobacco regulatory scenarios
Participants will complete three computer tasks simulating hypothetical regulatory scenarios and will earn and allocate puffs to study products. A greater proportion of puffs allocated will indicate greater demand for the product in that hypothetical scenario
Time frame: 1 month
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Oklahoma