Completed

Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2

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What is being tested

very low nicotine content cigarettes

+ Study e-cigarette

+ normal nicotine content cigarettes

Other
Who is being recruted

Vaping+7

+ Cigarette Smoking

+ Tobacco Smoking

Over 21 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: October 2022
See protocol details

Summary

Principal SponsorDuke University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 12, 2022

Actual date on which the first participant was enrolled.

Participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. During the screening session, participants will also be asked to complete surveys. Eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. During the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. They will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. The 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.

Official TitleImpact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
NCT05473585
Principal SponsorDuke University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

VapingCigarette SmokingTobacco SmokingBehaviorMental DisordersSmokingTobacco Use DisorderSubstance-Related DisordersChemically-Induced DisordersTobacco Use

Criteria

Inclusion Criteria: 1. Legal age to purchase tobacco products; 2. Regular user of EC and CC; 3. Owns the e-cigarette device used most often; 4. Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session; 5. Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid Exclusion Criteria: 1. Unstable medical conditions as determined by the licensed medical professional; 2. Unstable psychiatric conditions as determined by the licensed medical professional or PI; 3. Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy; 4. Serious quit attempt of either or both products in the past 3 months resulting in \>30 days of abstinence; 5. Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide; 6. Plans to quit use of either EC or CC, or all tobacco products in the next 45 days; 7. Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid; 8. Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): 1. Systolic blood pressure (BP) greater than or equal to 160 mm/hg 2. Diastolic BP greater than or equal to 100 mm/hg 3. Heart rate greater than or equal to 115 bpm; 9. Allergy to propylene glycol or vegetable glycerin; 10. Previous adverse reaction when using vaping device or e-liquid; 11. Current or recent alcohol or drug abuse problems; 12. Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months; 13. Literate and able to independently complete and comprehend the consent form and other written study materials and measures.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC

Group II

Active Comparator
Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC

Group III

Active Comparator
Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Duke University Medical Center

Durham, United StatesOpen Duke University Medical Center in Google Maps
CompletedOne Study Center