Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04709471 |
| Other study ID # |
STUDY00001093 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2021 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Vermont |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the
influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction
and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will
conduct a 4-week pilot RCT in which dual users who are not motivated to quit either product
in the near future are randomized to A) abruptly switch to low nicotine ENDS pods, B)
abruptly reduce number of usual nicotine ENDS pods, or C) use ENDS as usual (control). The
investigators adapted a protocol used in a prior study to assign participants to switch to
ENDS pods with less nicotine or reduce number of ENDS pods in this trial. Specifically, the
investigators will provide all participants with ENDS pods during the study period and
instruct them to only use ENDS provided by the study. Participants in reduced nicotine
condition will switch from usual nicotine (5% JUUL) to low nicotine ENDS (3% nicotine JUUL)
pods. Participants in the reduced use condition will continue to use usual nicotine ENDS (5%
nicotine JUUL) pods but reduce use to 60% of their baseline number of pods per week.
Participants in the control condition will use usual nicotine ENDS (5% nicotine JUUL) pods as
usual.
Description:
Background Use of Electronic Nicotine Delivery Systems (ENDS) has increased substantially in
the past decade, and nearly 70% of ENDS users also smoke cigarettes (i.e., dual users). There
is evidence that ENDS can be used as an effective smoking cessation aid. However, most dual
users use ENDS intermittently, which does not appear to promote smoking cessation. ENDS use
appears to be associated with increased overall nicotine addiction in some dual users and
could perpetuate or increase combustible cigarette (CC) smoking. These concerns have
contributed to policy changes to restrict ENDS use. For example the FDA's Center for Tobacco
Products finalized a rule to regulate ENDS and could reduce the amount of nicotine in ENDS.
Further, some states have begun to restrict access to ENDS. Market restrictions, FDA warning
labels, and public education messaging have the potential to reduce ENDS consumption. Little
is known, however, regarding the mechanisms of change in ENDS use that could affect nicotine
addiction and CC smoking in dual users. Thus, the investigators are conducting a pilot
randomized controlled trial (RCT) to test how change in ENDS nicotine (i.e. pharmacology) and
change in frequency of ENDS use (i.e., behavior) affects nicotine addiction and CC smoking
among dual users. Findings will inform understanding of how change in ENDS use contributes to
nicotine addiction and how regulation that results in reduced nicotine consumption from ENDS
could affect tobacco use among dual users.
Both pharmacological and behavioral factors contribute to nicotine dependence and thus could
be mechanisms by which change in ENDS affects addiction among dual users. Prior research
identified that switching to low nicotine CCs (i.e., change in pharmacology) and reduction in
number of CCs (i.e., change in behavior) independently reduced nicotine dependence and demand
for cigarettes within-participants over time. Similarly, observational data indicate that
self-selected use of lower nicotine content ENDS (i.e., pharmacology) and less frequent
vaping (i.e., behavior) appear to be associated with lower overall nicotine dependence among
dual users. However, there is a lack of experimental research on whether change in ENDS
nicotine content or frequency of use affects overall nicotine dependence among dual users.
Specific Aims
Primary Aim 1: To assess the feasibility of abruptly switching to low nicotine ENDS pods or
abruptly reducing number of ENDS pods.
Aim 2: To assess the influence of switching to reduced nicotine ENDS compared to ENDS use as
usual on CC smoking and nicotine dependence.
Aim 3: To assess the influence of reducing number of usual nicotine ENDS pods compared to
ENDS use as usual on CC smoking and nicotine dependence.
Secondary Aim 4: To assess the influence of switching to reduced nicotine ENDS pods compared
to reducing number of usual nicotine ENDS pods on CC smoking and nicotine dependence.
Methodology The procedures are based on a methodology demonstrated to be feasible in a prior
research. Potential participants who screen eligible will complete a videoconference call
with study personnel to 1) display their photo ID to confirm their identity, 2) display their
Juul device to confirm that they use Juul products, and 3) review the consent form.
Participants will provide written consent using the REDCap e-consent procedure. Consenting
participants will answer brief nightly questionnaires about the amount they smoke CCs and use
JUUL during a baseline week (week 0). During the baseline week (week 0) research personnel
will mail participants a personal iCO Smokerlyzer (https://www.covita.net/ico-overview/) for
remote breath carbon monoxide (CO) measurement. Research personnel will also mail a pregnancy
test to all female participants of reproductive potential (see Inclusion/Exclusion criteria
section below). At the end of the baseline week (week 0), participants will be emailed a link
to a REDCap survey to answer demographic and tobacco-related baseline questionnaires, to
report their breath CO level using their personal iCO Smokerlyzer, and, for women of
reproductive potential, to report the results of their pregnancy test. Women who are pregnant
or plan to become pregnant will not be eligible to participate in this study and will be
removed from this study if they become pregnant. At the end of the baseline (week 0) REDCap
survey, participants will be randomly assigned to A) abruptly switch to low nicotine ENDS
pods, B) abruptly reduce number of usual nicotine ENDS pods per week, or C) use ENDS as
usual. After completing the baseline REDCap survey, participants will be mailed their study
JUUL pods according to their condition. All participants will continue to complete brief
nightly questionnaires throughout the remaining 4-week study period. In addition,
participants will provide breath CO samples remotely using a personal iCO Smokerlyzer
provided by the study and complete tobacco related questionnaires remotely via REDCap at the
end of each week throughout the study period.
Participants will use their own JUUL products during baseline (week 0) and will be instructed
to only use JUUL products provided by the study throughout weeks 1 through 4. In order to
increase the validity of participants' self-reported adherence to study ENDS products (i.e.,
feasibility), the investigators will inform participants that self-reported noncompliance
will not influence their payment or future participation. At the end of week 0, the
investigators will provide participants with 4-week supplies of JUUL pods based on their
assigned condition and the number of pods they used during baseline (i.e. week 0) via mail.
The investigators will provide participants who are randomized to switch to low nicotine ENDS
with 100% of the number of JUUL pods/week used during the baseline week, but all JUUL pods
provided will have a nicotine content reduced to 60% of baseline (i.e., 3% nicotine JUUL
pods). The investigators will provide participants who are randomized to reduce number of
ENDS with approximately 60% of the number of JUUL pods/week used during the baseline week,
and all JUUL pods provided will have the regular nicotine content (i.e., 5% nicotine JUUL
pods). The investigators chose to reduce participants' number of JUUL pods to approximately
60% of baseline to match the 60% reduction in nicotine in the group assigned to switch from
usual (5%) to low (3%) nicotine JUUL pods. In addition, a similar magnitude of cigarette
reduction was feasible in a prior trial. Finally, participants randomized to use ENDS as
usual (control condition) will be provided with 100% of their baseline number of JUUL
pods/week containing regular nicotine content (5%). Participants in all conditions will have
the option to choose their preferred flavor of JUUL pods among the flavors sold legally in
Vermont when they are participating. The investigators will clearly and explicitly state that
they are not requiring participants to change CC smoking. Given the potential for
compensatory CC smoking during the study period, the study will have a data and safety
monitoring board (DSMB) review the study procedures and monitor participants' safety as
necessary.
At the end of week 4 the investigators will provide all participants with advice to quit all
tobacco products. They will also provide all participants a referral to the national quitline
for information on the benefits of quitting tobacco. In addition they will offer to mail a
one-month supply of nicotine replacement therapy (NRT) to participants who confirm they have
no contraindications for NRT to help them quit. Thus participants interested in NRT will
complete a brief screener via REDCap at the end of week 4. Participants who endorse a) Recent
heart attack (in last month), b) Heart disease that is untreated, c) Arrhythmia or irregular
heartbeat, d) High blood pressure not controlled by medications, e) An allergy to adhesive
tape, f) Skin problems that require treatment, or g) Stomach ulcer or diabetes will receive a
referral to the quitline but will not be eligible for NRT. The investigators will not provide
any participants with ENDS products after week 4 of the study period. Finally, all
participants will complete a web-based follow-up survey and provide a breath CO sample 4
weeks after study completion (i.e., 8 weeks after randomization) to assess tobacco use, ENDS
use, quit attempts, and behavioral economic measures.
