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

Duke University

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05473585

Pro00105539

5R01DA048454 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7 participants in 4 patient groups

Study EC + UB CC

Active Comparator group

Description:

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

Treatment:

Other: Study e-cigarette

Study EC + NNC CC

Active Comparator group

Description:

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

Treatment:

Other: normal nicotine content cigarettes

Other: Study e-cigarette

Study EC + VLNC CC

Experimental group

Description:

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

Treatment:

Other: very low nicotine content cigarettes

Other: Study e-cigarette

Own EC + UB CC

No Intervention group

Description:

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