A Study of Cigarette and ENDS Usage among Cigarette Smokers who Purchase an ENDS from a Vape Shop
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 15-003164
Sponsor Protocol Number: 15-003164
About this study
The purpose of this study is to assess whether regular cigarette smokers who purchase an ENDS product from Vape Shops that offer personalized coaching on product selection and use can result in regular cigarette smokers completely switching to an ENDS (i.e., discontinue cigarette smoking).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Consent—Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the consent form.
- Age—18 years of age or older
- General Health—Good general health with no clinically significant and relevant abnormalities of medical history based on patient’s self-reported medical history
- Smoking status—Smoked at least 10 cigarettes per day for the past six months.
- Motivated to completely switch to ENDS within the next 30 days.
- Purchasers of an ENDS device from a Vape Shop within 4 days after study enrollment.
- Carbon Monoxide—CO level greater than 5ppm at the Screening Visit.
- ENDS use—Using a tank or mod type ENDS no more than 5 days total prior to the purchase of an ENDS device from a vape shop.
Exclusion Criteria:
- Breast feeding – Women who are breastfeeding
- Use of any forms of nicotine, other than cigarettes or ENDS as defined in number 8 above, or any smoking cessation medications within 30 days before enrollment.
- Personnel—An employee of the study site, the study Vape Shop, or members of their immediate family
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Scott Leischow, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available