NCT03502200

Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures

Completed NA Results posted Last updated 21 July 2023

What this trial tests

NA trial testing JUUL in Smoking, Cigarette in 350 participants. Completed in 31 January 2023.

Timeline

15 October 2020

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Ohio State University Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	350
Start date	15 October 2020
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across United States

Drugs / interventions tested

• JUUL
• Treatment As Usual

Conditions studied

• Smoking, Cigarette — all drugs for Smoking, Cigarette →

Sponsor

Ohio State University Comprehensive Cancer Center

Who can join

Adults 21 to 99, any sex, with Smoking, Cigarette. 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.

Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes Primary · Daily for 12 weeks

Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.

Group	Value	95% CI
E-cigarette	41
Treatment As Usual	33

Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence Primary · 12 weeks

Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.

Group	Value	95% CI
E-cigarette	22
Treatment As Usual	17

Sociodemographic Questionnaire - Age Secondary · Baseline

Assess participant age from the sociodemographic questionnaire

Group	Value	95% CI
E-cigarette	55.26	± 12.66
Treatment As Usual	54.19	± 12.47

Sociodemographic Questionnaire - Sex Secondary · Baseline

Assess participant sex from the sociodemographic questionnaire

Group	Value	95% CI
E-cigarette	66
Treatment As Usual	68
E-cigarette	107
Treatment As Usual	105

Sociodemographic Questionnaire - Marital Status Secondary · Baseline

Assess participant marital status from the sociodemographic questionnaire

Group	Value	95% CI
E-cigarette	55
Treatment As Usual	56
E-cigarette	50
Treatment As Usual	46
E-cigarette	23
Treatment As Usual	23
E-cigarette	16
Treatment As Usual	18

Sociodemographic Questionnaire - Ethnicity Secondary · Baseline

Assess participant ethnicity from the sociodemographic questionnaire

Group	Value	95% CI
E-cigarette	2
Treatment As Usual	2
E-cigarette	170
Treatment As Usual	171
E-cigarette	3
Treatment As Usual	2

Sociodemographic Questionnaire - Employment Status Secondary · Baseline

Assess participant employment status from the sociodemographic questionnaire

Group	Value	95% CI
E-cigarette	8
Treatment As Usual	12
E-cigarette	26
Treatment As Usual	32
E-cigarette	11
Treatment As Usual	13
E-cigarette	17
Treatment As Usual	21

Sociodemographic Questionnaire - Socioeconomic Status Secondary · Baseline

Assess participant socioeconomic status via yearly household income

Group	Value	95% CI
E-cigarette	136
Treatment As Usual	136
E-cigarette	34
Treatment As Usual	33

Cigarette/EC Dependency Scale Secondary · 12 weeks

Assess e-cigarette and cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.

Cigarette Dependence Scale

Group	Value	95% CI
E-cigarette	14.42	± 4.51
Treatment As Usual	14.11	± 4.60

e-Cigarette Dependence Scale

Group	Value	95% CI
E-cigarette	12.63	± 4.99

Drug Effects/Liking Questionnaire Secondary · 12 weeks

Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)

Effect from smoking cigarettes

Group	Value	95% CI
E-cigarette	2.81	± 1.32
Treatment As Usual	3.20	± 1.30

Liking of effect after smoking cigarettes

Group	Value	95% CI
E-cigarette	3.16	± 1.17
Treatment As Usual	2.97	± 1.23

Effect from vaping e-cigarette

Group	Value	95% CI
E-cigarette	2.80	± 1.10

Liking of effect from vaping e-cigarette

Group	Value	95% CI
E-cigarette	3.39	± 1.07

Cigarette Purchase Task - Breakpoint Secondary · Week 1 (Baseline)

Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their own brand cigarette. Specifically they will be asked, "How much would you be willing to pay for a puff of your usual cigarette brand?".

Group	Value	95% CI
E-cigarette	2.62	± 11.16
Treatment As Usual	5.96	± 27.42

Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU) Secondary · 12 Weeks

Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette") for EC users. This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculate

QSU Desire (cigarette)

Group	Value	95% CI
E-cigarette	12.97	± 9.72
Treatment As Usual	13.66	± 10.38

QSU Relief (cigarette)

Group	Value	95% CI
E-cigarette	10.13	± 7.98
Treatment As Usual	10.22	± 7.37

QSU Desire (e-cigarette)

Group	Value	95% CI
E-cigarette	16.76	± 10.71

QSU Relief (e-cigarette)

Group	Value	95% CI
E-cigarette	11.82	± 8.26

QSU Desire (NRT)

Group	Value	95% CI
Treatment As Usual	10.56	± 8.41

QSU Relief (NRT)

Group	Value	95% CI
Treatment As Usual	8.69	± 6.84

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

E-cigarette

Serious: 18/175 (10%)

Deaths: 0/175

Treatment As Usual

Serious: 10/175 (6%)

Deaths: 2/175

Serious adverse events (28 terms)

Reaction	System	E-cigarette	Treatment As Usual
Breathing Difficulties	Respiratory, thoracic and mediastinal disorders	—	—
Breast Cancer	Reproductive system and breast disorders	—	—
Ulcer	Gastrointestinal disorders	—	—
Broken Back	Musculoskeletal and connective tissue disorders	—	—
Carotid Endarterectomy Surgery	Surgical and medical procedures	—	—
Chest Pain	Respiratory, thoracic and mediastinal disorders	—	—
Chest Pain	Cardiac disorders	—	—
Chest Pain	General disorders	—	—
Cuff Repair Surgery	Blood and lymphatic system disorders	—	—
Dental Problems	Surgical and medical procedures	—	—
Depression	Psychiatric disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Essential Tremor Worsening	Nervous system disorders	—	—
Exploratory Larynx Surgery	Respiratory, thoracic and mediastinal disorders	—	—
Gallbladder Problems	Hepatobiliary disorders	—	—
Gastrointestinal Problems	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Heart Condition	Cardiac disorders	—	—
Heart Palpitations	Cardiac disorders	—	—
Hernia	Surgical and medical procedures	—	—
Myocardial Infarction	Cardiac disorders	—	—
Needed Medication Adjustment for Bipolar Schizoaffective Disorder	Psychiatric disorders	—	—
Pancreatic Pain	Gastrointestinal disorders	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	E-cigarette	Treatment As Usual
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Sore or Dry Mouth and Throat	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Blood and lymphatic system disorders	—	—
Allergies	Immune system disorders	—	—
Sleeplessness	Psychiatric disorders	—	—
Mouth or Tongue Sores or Inflammation	Gastrointestinal disorders	—	—
Sleeplessness	Nervous system disorders	—	—
Sleepiness	Nervous system disorders	—	—
Breathing Difficulties	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Breathing Difficulties, Breast Cancer, Ulcer, Broken Back, Carotid Endarterectomy Surgery, Chest Pain, Chest Pain, Chest Pain.

Data from ClinicalTrials.gov NCT03502200 adverse events section.

Sponsor's own description

The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. E-cigarettes versus combination nicotine replacement therapy following a recent failed quit attempt: a pragmatic randomized trial through state tobacco quitlines.
   Wagener TL, Hinton A, Brasky TM, Cho YJ, et al · · 2026 · PMID 41551921 · DOI 10.1016/j.lana.2025.101351