NCT05320887

Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)

Completed NA Results posted Last updated 9 October 2024

What this trial tests

NA trial testing Normal Nicotine Content Vape with all flavor e-liquids in Tobacco Use in 69 participants. Completed in 6 August 2023.

Timeline

27 July 2022

Primary endpoint
31 July 2023

6 August 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	health services research
Enrollment	69
Start date	27 July 2022
Primary completion	31 July 2023
Estimated completion	6 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Normal Nicotine Content Vape with all flavor e-liquids
• Normal nicotine content vape with tobacco e-liquids
• Low nicotine content vape with all flavor e-liquids
• Low nicotine content vape with tobacco e-liquids

Conditions studied

• Tobacco Use — all drugs for Tobacco Use →

Sponsor

Wake Forest University Health Sciences

Who can join

21 and older, any sex, with Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Cigarettes Purchased Primary · Visit 6 approximately 4 weeks after baseline

Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	154.7	± 131.7
Low Nicotine Content Vape With Tobacco E-liquids	119.2	± 55.5

Number of E-liquid Milliliters Purchased Secondary · Visit 6 approximately 4 weeks after baseline

Average number of e-liquid milliliters purchased (analyzed as raw data and using derived behavioral economic measures)

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	36.7	± 24.1
Low Nicotine Content Vape With Tobacco E-liquids	35.0	± 29.6

Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections Secondary · Month 1 after baseline

The proportion of participants projected to choose a cigarette over an e-cigarette under different potential regulatory scenarios, as determined by regression analysis.

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	41.8
Low Nicotine Content Vape With Tobacco E-liquids	61.9

Lung Cancer Perceived Risk Scores for VLNC Cigarettes Secondary · Baseline

The response options rely on a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer.

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	5.4	± 2.9
Low Nicotine Content Vape With Tobacco E-liquids	4.2	± 2.9

Product Evaluation Scale Scores Secondary · Visit 6 approximately 4 weeks after baseline

Product evaluation scale scores for VLNC cigarettes among participants who received VLNC cigarettes will be determined by a product evaluation questionnaire. The questionnaire measures the strength of self-reported positive subjective effects (e.g., reward, satisfaction) following product use. The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely. The summed score adds responses to 13 separate items. Minimum possible response: 13. Maximum possible response: 91. Higher scores denote more favorab

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	29.1	± 15.3
Low Nicotine Content Vape With Tobacco E-liquids	29.1	± 17.0

Minnesota Nicotine Withdrawal Scale Scores Secondary · Visit 6 approximately 4 weeks after baseline

Minnesota Nicotine Withdrawal Scale measures the severity of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe. There are 7 items total, that are summed. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms.

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	5.3	± 5.9
Low Nicotine Content Vape With Tobacco E-liquids	4.9	± 7.0

Questionnaire on Smoking Urges Score Secondary · Visit 6 approximately 4 weeks after baseline

Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke.

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	36.1	± 18.7
Low Nicotine Content Vape With Tobacco E-liquids	32.4	± 19.2

Tobacco Product Interest Scores Secondary · 1 month after baseline

Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested

UB Cigs

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	87.2	0 – 100
Low Nicotine Content Vape With Tobacco E-liquids	88.4	0 – 100

VLNC

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	27.1	0 – 100
Low Nicotine Content Vape With Tobacco E-liquids	32.2	0 – 100

Pod E-Cig

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	38.3	0 – 100
Low Nicotine Content Vape With Tobacco E-liquids	33.2	0 – 100

Mod E-Cig

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	15.4	0 – 100
Low Nicotine Content Vape With Tobacco E-liquids	35.6	0 – 100

Pen E-Cig

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	31.0	0 – 100
Low Nicotine Content Vape With Tobacco E-liquids	40.3	0 – 100

Tobacco Policy Questionnaire Scores Secondary · 1 month after baseline

Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on Making Cigarettes Less Addictive

Support

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	15
Low Nicotine Content Vape With Tobacco E-liquids	11

Oppose

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	7
Low Nicotine Content Vape With Tobacco E-liquids	11

Don't Know

Group	Value	95% CI
Normal Nicotine Content Vape With Tobacco E-liquids	7
Low Nicotine Content Vape With Tobacco E-liquids	10

Adverse events — posted to ClinicalTrials.gov

Time frame: Screening visit through end of study (up to week eight). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Normal Nicotine Content Vape With All Flavor E-liquids

Serious: 0

Deaths: 0

Normal Nicotine Content Vape With Tobacco E-liquids

Serious: 0/29 (0%)

Deaths: 0/29

Low Nicotine Content Vape With All Flavor E-liquids

Serious: 0

Deaths: 0

Low Nicotine Content Vape With Tobacco E-liquids

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (2 terms — click to expand)

Reaction	System	Normal Nicotine Content Va…	Normal Nicotine Content Va…	Low Nicotine Content Vape …	Low Nicotine Content Vape …
Stress/Irritability	Psychiatric disorders	—	—	—	—
COVID	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT05320887 adverse events section.

Sponsor's own description

This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.