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Completed

NCT Number: NCT06087328

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

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.

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Key information

Conditions

Smoking Cessation Behavior Cigarette Smoking Electronic Cigarette Use Health Behavior Smoking Tobacco Smoking Tobacco Use Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina - Charleston

Charleston, South Carolina, 29403, United States

About this study

Tobacco use is a leading cause of cancer death and disability in the US, thus tobacco control remains an important public health priority. Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping). E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking. Recent estimates suggest that 54% of those who vape are currently smoking (i.e., dual use). Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population. In a prior pilot study, investigators found preliminary evidence that a standard dose of nicotine replacement therapy (NRT; 21mg patch+4mg lozenge) was sufficient at helping exclusive e-cigarette users quit vaping. However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly. The proposed project aims to compare three doses of NRT (21mg patch+4mg lozenge; 21+14mg patch + 4mg lozenges; 21+21mg patch + 4mg lozenges) with a sample of dual users who wish to quit smoking and vaping use in order to understand more about how NRT can help dual users quit tobacco.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Regular Nicotine patch and lozenge dose

Drug

1mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day]

Augmented Nicotine patch and lozenge dose

Drug

21mg patch + 14mg patch qd + 4mg lozenge prn [minimum of 5 & up to 30 per day] OR 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day]

Primary outcomes

  1. Days of Dual Use Abstinence

    Time frame: Day 28, Day 56

    Number of days participants self-report abstinence from both e-cigarettes and smoking.

Secondary outcomes

  1. Reduction

    Time frame: Day 28, Day 56

    Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment.

  2. Safety (Adverse Events)

    Time frame: Day 28

    Adverse events and outcomes between groups will be evaluated.

  3. Feasibility/Acceptability

    Time frame: Day 28

    Feasibility and acceptability were assessed by the proportion of eligible participants who enrolled, and among enrolled participants, the proportion who completed the Day 28 survey and the proportion who completed ≥80% of daily surveys during treatment.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes

Acronym: CAN-DOSE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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