Clinical trial NCT05473585: Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Official title: Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking, Cigarette
E-Cig Use
Nicotine Dependence
Keywords: Nicotine Reduction
Dual users
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-07-26
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete 4 experimental sessions. At each session, they will receive a different combination of e-cigarette and combusted cigarette.
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Number of choices for CC during preference task
timeFrame: during preference session, approximately 2 hours
Secondary outcomes:
measure: Number of choices for EC during preference task
timeFrame: during preference session, approximately 2 hours
measure: Number of choices to abstain during preference task
timeFrame: during preference session, approximately 2 hours
measure: Cigarette Evaluation Scale
timeFrame: during preference session, approximately 2 hours
measure: Perceived health risk
timeFrame: during preference session, approximately 2 hours
measure: Craving
timeFrame: during preference session, approximately 2 hours
measure: Product Valuation
timeFrame: during preference session, approximately 2 hours
measure: CO boost
timeFrame: during preference session, approximately 2 hours
measure: Cross Price Elasticity
timeFrame: during preference session, approximately 2 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis McClernon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: