Phase 2 N=46 Randomized Treatment

CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes

Smoking Cessation · Electronic Cigarette Use · Cigarette Smoking

Bottom Line

View on ClinicalTrials.gov: NCT06087328 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Days of Dual Use Abstinence — 3.8; 11.2; 6.9; 4.6 Days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Regular Nicotine patch and lozenge dose (Drug); Augmented Nicotine patch and lozenge dose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Days of Dual Use Abstinence	3.8; 11.2; 6.9; 4.6; 23.8; 16.1	—
SECONDARY Reduction	6.1; 13.5; 9.5; 7.9; 16.4; 12.2	—
SECONDARY Safety (Adverse Events)	9; 13; 10; 0; 1; 0	—
SECONDARY Feasibility/Acceptability	46; 0; 0; 0; 0; 0	—

Summary

Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.

Eligibility Criteria

Inclusion Criteria

Age 18yrs +
Daily nicotine-containing e-cigarette user (25+ days per previous month)
E-cigarette use 5+ times/day
E-cigarette use > 1year
Smoking >1 cigarette on 5-7 days per week
Interest in quitting smoking and e-cigarette within the next month (>7 on 10-point scale)
Willingness to use NRT
Able to receive text messages/email
Mailing address in South Carolina.

Exclusion Criteria

Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated)
Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications
Those who vape non-nicotine substances
Individuals unable to consent (e.g. significant cognitive deficit, non-English speaking).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06087328). 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.