N/A
N=350
Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures
Smoking, Cigarette
Bottom Line
View on ClinicalTrials.gov: NCT03502200 ↗Enrolled (actual)
350
Serious AEs
8.0%
Results posted
Jul 2023
Primary outcome: Primary: Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes — 41; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- JUUL (Device); Treatment As Usual (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes |
41; 33 | — |
| PRIMARY Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence |
22; 17 | — |
| SECONDARY Sociodemographic Questionnaire - Age |
55.26; 54.19 | — |
| SECONDARY Sociodemographic Questionnaire - Sex |
66; 68; 107; 105 | — |
| SECONDARY Sociodemographic Questionnaire - Marital Status |
55; 56; 50; 46; 23; 23 | — |
| SECONDARY Sociodemographic Questionnaire - Ethnicity |
2; 2; 170; 171; 3; 2 | — |
| SECONDARY Sociodemographic Questionnaire - Employment Status |
8; 12; 26; 32; 11; 13 | — |
| SECONDARY Sociodemographic Questionnaire - Socioeconomic Status |
136; 136; 34; 33 | — |
| SECONDARY Cigarette/EC Dependency Scale |
14.42; 14.11; 12.63 | — |
| SECONDARY Drug Effects/Liking Questionnaire |
2.81; 3.20; 3.16; 2.97; 2.80; 3.39 | — |
| SECONDARY Cigarette Purchase Task - Breakpoint |
2.62; 5.96 | — |
| SECONDARY Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU) |
12.97; 13.66; 10.13; 10.22; 16.76; 11.82 | — |
| SECONDARY Minnesota Nicotine Withdrawal Scale |
1.24; 1.38; 1.98; 2.22 | — |
| SECONDARY Change in Motivation Rulers (Scale) From Baseline to Week 12 |
0; 0; -0.5; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- smoke ≥5 cigarettes per day for the past year
- read, write, and speak in English
- report at least minimal interest in switching to an alternative product (> "not at all" on a Likert scale)
- participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months.
Exclusion Criteria
- <21 years old
- report NRT use or making a quit attempt within the last 7 days
- current daily use of an e-cigarette over last month.
- unstable or significant medical condition such as respiratory, kidney, or liver disease
- unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- history of cardiac event or distress within the past 6 months
- currently pregnant, planning to become pregnant, or breastfeeding.
- currently enrolled in a contradictory study.
- cohabitates with a currently enrolled participant in the REACH study
- reaction to using patch medication or adhesive tape
- known allergy to propylene glycol or vegetable glycerin
Data sourced from ClinicalTrials.gov (NCT03502200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.