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

NCT06087328 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: Pro00130184IRG-19-137-20
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Electronic Cigarette Use; Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Days of Dual Use Abstinence

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

  Day 28, Day 56

Secondary Outcomes (3)

• Reduction

  Day 28, Day 56

• Safety (Adverse Events)

  Day 28

• Feasibility/Acceptability

  Day 28

Study Arms (3)

Arm A

ACTIVE COMPARATOR

21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]

Drug: Regular Nicotine patch and lozenge dose

Arm B

ACTIVE COMPARATOR

21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]

Drug: Augmented Nicotine patch and lozenge dose

Arm C

ACTIVE COMPARATOR

2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]

Drug: Augmented Nicotine patch and lozenge dose

Interventions

Regular Nicotine patch and lozenge dose DRUG

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

Arm A

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 \[minimum of 5 \& up to 40 per day\]

Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Medical University of South Carolina - Charleston

Charleston, South Carolina, 29403, United States

Location

Related Publications (1)

• Palmer AM, DeMass R, Rojewski AM, Bagley EM, Carpenter MJ, Smith TT, Toll BA. Augmented Doses of Nicotine Replacement Therapy: Feasibility for Dual Cigarette and E-Cigarette Cessation. Am J Prev Med. 2025 Aug;69(2):107664. doi: 10.1016/j.amepre.2025.107664. Epub 2025 May 21.

  PMID: 40409566 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Vaping; Cigarette Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Smoking; Tobacco Use

Limitations and Caveats

Feasibility measures were assessed separately for two populations: eligible participants and enrolled participants. As a result, certain rows in the outcome table have zero analyzed counts because those measures were not applicable to that arm.

Results Point of Contact

• Title: Amanda M. Palmer, PhD
• Organization: Medical University of South Carolina

palmeram@musc.edu

843-792-1413

Study Officials

• Amanda Palmer

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: December 5, 2023
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Locations

US (1)