Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04805515 |
Other study ID # |
00001374 |
Secondary ID |
R01DA051001 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 12, 2021 |
Est. completion date |
May 31, 2021 |
Study information
Verified date |
November 2022 |
Source |
University of Vermont |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a 2-arm, randomized controlled, population based trial to test the impact of multiple
exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and
non-smokers followed in waves over 12 weeks. The primary outcome, assessed at wave 1
(baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary
outcomes assessed at the same time points include intention to use nicotine/tobacco products
and nicotine/tobacco use.
Description:
This is a 2-arm, randomized controlled, population based trial to test the impact of multiple
exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and
non-smokers followed for 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2
(weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the
same time points include intention to use nicotine/tobacco products and nicotine/tobacco use.
All participants will be recruited from a US national consumer research panel. Eligible
participants will be U.S. adults ages 18+ who are enrolled members of the partnering consumer
research panel. The sample will include non-smokers and smokers, oversampling current smokers
(defined as smoking 100+ lifetime cigarettes and now smoking all or some days) to ensure the
proportion of smokers in the sample reflects the ~15 % population smoking prevalence among
adults. Panel members will be contacted by email with a brief study description and link to
an eligibility screener and online informed consent form. Eligible and interested
participants will complete the baseline (Wave 1) survey measures of nicotine beliefs and
intentions/use of nicotine and tobacco products, after which they will be randomly assigned
in equal numbers to the nicotine corrective message (NCM) intervention condition or the
delayed message control condition. After completing the baseline survey, participants in the
NCM condition will receive their first exposure to the corrective messages. In the Wave 2
survey, all participants will complete measures of nicotine beliefs and intentions/use of
nicotine and tobacco products. Participants in the NCM condition will then receive their
second exposure to study messages. Only participants in the NCM condition will receive the
Wave 3 survey, which involves the third exposure to study messages. The Wave 4 survey will
include the fourth exposure to study messages for those in the NCM condition and the final
assessment of nicotine beliefs and intentions/use of nicotine and tobacco products for all
participants. Upon completion of the final assessment, participants in the control condition
will be exposed to the nicotine corrective messages and all participants will be directed to
resources on quitting smoking.