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

NCT05473585 | Completed

• 2 other identifiers: Pro001055395R01DA048454
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. Eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.

Conditions

Smoking; Smoking, Cigarette; E-Cig Use; Nicotine Dependence

Keywords

Nicotine Reduction; Dual users

Outcome Measures

Primary Outcomes (1)

• Number of choices for CC during preference task

  Participants will complete a preference task during which they will choose to take puffs from the session EC, the session CC, or to abstain from taking any puffs. A total of 10 trials will be completed. The number of choices for CC will be compared across the preference sessions.

  during preference session, approximately 2 hours

Secondary Outcomes (8)

• Number of choices for EC during preference task

  during preference session, approximately 2 hours

• Number of choices to abstain during preference task

  during preference session, approximately 2 hours

• Cigarette Evaluation Scale

  during preference session, approximately 2 hours

• Perceived health risk

  during preference session, approximately 2 hours

• Craving

  during preference session, approximately 2 hours

Study Arms (4)

Study EC + UB CC

ACTIVE COMPARATOR

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

Other: Study e-cigarette

Study EC + NNC CC

ACTIVE COMPARATOR

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

Other: normal nicotine content cigarettes; Other: Study e-cigarette

Study EC + VLNC CC

EXPERIMENTAL

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

Other: very low nicotine content cigarettes; Other: Study e-cigarette

Own EC + UB CC

NO INTERVENTION

Participants will make choices between their own EC device with their own tobacco flavor and their UB CC

Interventions

very low nicotine content cigarettes OTHER

Investigational combusted cigarettes with very low nicotine content

Also known as: VLNC

Study EC + VLNC CC

normal nicotine content cigarettes OTHER

Investigational combusted cigarettes with normal nicotine content

Also known as: NNC

Study EC + NNC CC

Study e-cigarette OTHER

E-cigarette provided by study

Study EC + NNC CC; Study EC + UB CC; Study EC + VLNC CC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legal age to purchase tobacco products;
• Regular user of EC and CC;
• Owns the e-cigarette device used most often;
• Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session;
• Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid

You may not qualify if:

• Unstable medical conditions as determined by the licensed medical professional;
• Unstable psychiatric conditions as determined by the licensed medical professional or PI;
• Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy;
• Serious quit attempt of either or both products in the past 3 months resulting in \>30 days of abstinence;
• Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide;
• Plans to quit use of either EC or CC, or all tobacco products in the next 45 days;
• Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid;
• Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
• Systolic blood pressure (BP) greater than or equal to 160 mm/hg
• Diastolic BP greater than or equal to 100 mm/hg
• Heart rate greater than or equal to 115 bpm;
• Allergy to propylene glycol or vegetable glycerin;
• Previous adverse reaction when using vaping device or e-liquid;
• Current or recent alcohol or drug abuse problems;
• Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months;

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking; Cigarette Smoking; Vaping; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Francis McClernon, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete 4 experimental sessions. At each session, they will receive a different combination of e-cigarette and combusted cigarette.

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 26, 2022
• Study Start: October 12, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)