Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use
Understanding the Real-World Impact of the Use of Three Alternate Nicotine-Delivery Products on Combustible Cigarette Use
5 other identifiers
interventional
209
1 country
2
Brief Summary
The goal of this research is to understand the potential impact of two new FDA strategies to ensure the availability of safer Alternative Nicotine Delivery Systems (ANDS) and to reduce the nicotine content in combustible cigarettes to non-addictive levels. Specifically, this research will examine how well ANDS and very low nicotine cigarettes (VLNCs) can work alone or in combination with the current strategy of providing a safe source of nicotine via nicotine replacement medications to reduce use of combustible cigarettes, in real-world settings. The investigators will enroll 180 daily adult smokers who are not planning to quit smoking within the next 30 days into this mixed design study. Participants will be randomly assigned to one of three levels of the between-subjects factor: 1) VLNC cigarettes; 2) Juul e-cigarettes (with nicotine); or 3) no alternative product. Participants receiving an alternative product (VLNC or e-cigarettes) will be asked to use it for 4 weeks (Weeks 1 through 4). During Weeks 2 and 4 all participants will be asked to switch from their cigarettes to use only study products (i.e., Juul e-cigarettes, VLNCs, or no alternative product) and to use either an active nicotine or placebo patch (the within-subjects factor), provided in double-blind fashion and counterbalanced order. During Weeks 1 through 4, participants will use a smartphone to record, in the moment, each time they use their own cigarettes or any alternative product. For a random daily subset of use events, participants will complete additional questions about the internal and external context of their use (e.g., affect, any restrictions on smoking) and their response to use (e.g., withdrawal alleviation, taste, satisfaction). Using these data, the investigators will also examine the effects of these products on the rewarding value of smoking and possible mechanisms driving such behavior (e.g., withdrawal alleviation, satisfaction, taste). This research will provide critical information regarding the potential impact of providing cigarettes with non-addictive levels of nicotine and safe ANDS, with or without nicotine replacement, in real-world settings on smokers' use of their usual cigarettes and other outcomes. Information on the short-term effects of products that could be accessible in the future will provide data that could inform regulatory policy decisions regarding the public health impact of safe ANDS and non-addictive cigarettes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2022
CompletedResults Posted
Study results publicly available
May 25, 2023
CompletedMay 25, 2023
May 1, 2023
1.7 years
September 5, 2019
February 2, 2023
May 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Number of Conventional Cigarettes Smoked During Each Switch Week
The mean number of conventional cigarettes smoked during each Switch Week will be used as a measure for conventional cigarette usage.
During the two 1-week switching periods
Secondary Outcomes (1)
Mean Number of VLNCs Smoked or Vape Events Per Day Reported During Each Switch Week
During the two 1-week switching periods
Study Arms (6)
Juul + Active Patch in Wk 1 and Placebo Patch in Wk 2
ACTIVE COMPARATORParticipants will be given Juul e-cigarettes for four weeks; in Switch Week 1, participants also will use active nicotine patches; in Switch Week 2, participants will use placebo patches.
Juul + Placebo Patch in Wk 1 and Active Patch in Wk 2
ACTIVE COMPARATORParticipants will be given Juul e-cigarettes for four weeks; in Switch Week 1, participants also will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
VLNC + Active Patch in Wk 1 and Placebo Patch in Wk 2
ACTIVE COMPARATORParticipants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1, participants also will use active nicotine patches; in Switch Week 2, participants will use placebo patches.
VLNC + Placebo Patch in Wk 1 and Active Patch in Wk 2
ACTIVE COMPARATORParticipants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1, participants also will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
No Product + Active Patch in Wk 1 and Placebo Patch in Wk 2
OTHERParticipants will be given no alternative nicotine delivery products but in Switch Week 1, participants will use active nicotine patches; in Switch Week 2, participants will use placebo patches.
No Product + Placebo Patch in Wk 1 and Active Patch in Wk 2
OTHERParticipants will be given no alternative nicotine delivery products for two weeks but in Switch Week 1 participants will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
Interventions
The juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
Active nicotine patches, with dosing based on the package insert (\>10 cigs/day = 21 mg patch and \<11 cigs/day = 14 mg patches).
Placebo patch containing no nicotine.
Eligibility Criteria
You may qualify if:
- smoking \>4 cigarettes/day for the previous 6 months
- able to read, write, and speak English
- no plans to quit smoking in the next 30 days
- not currently taking smoking cessation medication
- willing and medically able to use nicotine patches
- exhaled carbon monoxide (CO) \> 6 ppm.
You may not qualify if:
- currently in treatment for psychosis or bipolar disorder
- e-cigarette use within the last month
- currently pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
University of Wisconsin Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711, United States
UW Center for Tobacco Research and Intervention
Milwaukee, Wisconsin, 53233, United States
Related Publications (1)
Piper ME, Kaye JT, Piasecki TM, Yang JJ, Buu A. Cannabis use among adults who smoke tobacco: Relations with switching from combusted cigarettes to e-cigarettes or very low nicotine cigarettes. Drug Alcohol Depend. 2025 Oct 1;275:112821. doi: 10.1016/j.drugalcdep.2025.112821. Epub 2025 Aug 6.
PMID: 40803048DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Megan Piper, PhD, Director of Research Professor
- Organization
- University of Wisconsin- Madison
Study Officials
- PRINCIPAL INVESTIGATOR
Megan E Piper, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants will be randomly assigned to Juul, Very Low Nicotine Cigarette, or No Product with no masking of product type. However, participants will be randomly assigned to receive either placebo or active nicotine patch with masking regarding placebo vs active patch.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2019
First Posted
September 10, 2019
Study Start
September 9, 2020
Primary Completion
May 23, 2022
Study Completion
May 23, 2022
Last Updated
May 25, 2023
Results First Posted
May 25, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After the publication of the main findings
- Access Criteria
- Approval of a data request by the investigators
We will make the set of final de-identified datasets available in encrypted standard file formats or secure File Transfer Protocol (FTP) transmission by request from other researchers in a timely manner (no later than the acceptance for publication of the main findings from the final dataset).