Phase 2
Completed N=396
Quit Smoking Study for People Who Use E-Cigarettes
Nicotine Addiction · E-Cig Use · Quitting Smoking
Source: ClinicalTrials.gov NCT04946825 ↗
Enrolled (actual)
396
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Biochemically Confirmed 7-day Point-prevalence Cigarette Abstinence — 16; 26; 16; 16 Participants
Summary
The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of combustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a 2x2 factorial design to randomize 390 participants to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. The investigators primary outcome will be 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). The investigators will recruit participants using national advertising strategies. All treatment will be provided remotely in order to increase treatment access and comply with current COVID-19 restrictions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically Confirmed 7-day Point-prevalence Cigarette Abstinence |
16; 26; 16; 16 | — |
| PRIMARY Self-reported 7-day Point-prevalence Cigarette Abstinence |
44; 56; 40; 39 | — |
| PRIMARY Adverse Events During Treatment |
7; 11; 8; 12 | — |
| SECONDARY Biochemically Confirmed Prolonged 30-day Abstinence |
10; 21; 13; 12 | — |
| SECONDARY Self-reported Prolonged 30-day Abstinence |
27; 48; 31; 28; 44; 43 | — |
| SECONDARY Any Attempts to Quit Combustible Cigarettes |
89; 100; 92; 88 | — |
| SECONDARY Cigarettes Per Day |
4.67; 4.67; 4.37; 4.84 | — |
| SECONDARY Cigarette Dependence |
1.78; 1.71; 1.58; 1.70 | — |
Eligibility Criteria
Inclusion criteria
- Young adult
- Smokes tobacco cigarettes
- Uses electronic cigarettes
- Interested in quitting tobacco
Exclusion criteria
- Pregnant or planning to become pregnant
- Breastfeeding or planning to start breastfeeding
- One or more contraindications for nicotine replacement therapy
Additional criteria will be assessed to determine eligibility.
If you are interested in participating, please visit the study website to find out if you are eligible: https://www.uvmquitsmokingstudy.org/
Data sourced from ClinicalTrials.gov (NCT04946825). 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. Informational only — not medical advice.