Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and… (NCT02964182) | Clinical Trial Compass
CompletedNot Applicable
Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers
United States213 participantsStarted 2017-10-26
Plain-language summary
This trial studies what would happen if the nicotine levels in cigarettes are greatly reduced, but electronic cigarettes containing different amount of nicotine are available. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes in smoking behavior in current daily and intermittent smokers..
Who can participate
Age range21 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sign consent and agree to all study procedures
* Have an address where he/she can receive mail
* Have a device available to conduct telehealth visit (e.g., smartphone, computer, tablet, internet access, etc.)
* Able to follow verbal and written instructions in English
* Willing and able to complete two spirometry sessions (this criterion waived during COVID-19 pandemic)
* Be the only participant in their household
* Interested in trying novel nicotine products
* Daily smokers: \>= 1 cigarette/little cigar per day
* Intermittent smokers: \>= 1 cigarette/little cigar per day 4 to 27 days per month
* Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to each in-person research visit
* The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle
Exclusion Criteria:
* Unwilling to refrain from other e-cigarette use for the duration of the study, other than what is provided to them for study purposes
* Current/recent use of certain medications:
* Smoking cessation meds (past 90 days; e.g., wellbutrin, bupropion, Zyban, nicotine replacement therapy \[NRT\], Chantix)
* Certain medications to treat depression (last 14 days; e.g., amitriptyline)
* A case by case determination will be made by study physician for medication on the precautionary list, (e.g. nitroglycerin)
* Self-reported daily use of opioids for 30 days or more on phone screen or at scr…