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| ID | Type | Description | Link |
|---|---|---|---|
| IRG-19-137-20 | Other Grant/Funding Number | American Cancer Society Institutional Research Grant |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | 21mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day] |
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| Arm B | Active Comparator | 21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 & [up to 30 per day] |
|
| Arm C | Active Comparator | 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular Nicotine patch and lozenge dose | Drug | 1mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days of Dual Use Abstinence | Number of days participants self-report abstinence from both e-cigarettes and smoking. | Day 28, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction | Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment. | Day 28, Day 56 |
| Safety (Adverse Events) | Adverse events and outcomes between groups will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Palmer | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina - Charleston | Charleston | South Carolina | 29403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409566 | Derived | 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. |
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Following consent, all females underwent a pregnancy test to ensure final eligibility for the study prior to randomization.
From December 2023-September 2024, 46 participants were recruited from online advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | 21mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day] |
| FG001 | Arm B | 21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 & [up to 30 per day] |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 28-Day Treatment |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2023 |
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| 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] |
|
| Day 28 |
| Feasibility/Acceptability | 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. | Day 28 |
| FG002 | Arm C | 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day] |
| COMPLETED |
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| NOT COMPLETED |
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| 1-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | 21mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day] |
| BG001 | Arm B | 21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 & [up to 30 per day] |
| BG002 | Arm C | 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day] |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Participants self-reported ethnicity as Hispanic/Latino or Non-Hispanic/Latino. A 'Not Reported' category was included for missing responses. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Participants self-reported race. Categories included: American Indian or Alaskan Native, Asian, Black or African American, White or Caucasian, and Multiracial. A 'Not Reported' category was included for completeness; Two participants did not provide race information and are included in the 'Not Reported' category.". | Count of Participants | Participants |
| |||||||||||||||
| Dependence | Dependence score was used as a stratification variable. Dependence Score was determined by the highest score between the Fagerstrom Test for Nicotine Dependence (FTND) or Roswell ENDS Nicotine Dependence Scale (eNDS) with "low" categorized as scores 1-5 and "high" categorized as 6-10, respectively. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Days of Dual Use Abstinence | Number of days participants self-report abstinence from both e-cigarettes and smoking. | Posted | Mean | Standard Deviation | Days | Day 28, Day 56 |
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| Secondary | Reduction | Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment. | Posted | Mean | Standard Deviation | Days | Day 28, Day 56 |
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| Secondary | Safety (Adverse Events) | Adverse events and outcomes between groups will be evaluated. | Posted | Count of Participants | Participants | Day 28 |
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| Secondary | Feasibility/Acceptability | 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. | Participants in the 'Eligible and Contacted' arm were only assessed for enrollment; survey completion was not measured. Participants in the 'Enrolled' arm were only assessed for survey completion; enrollment was not measured. Therefore, some rows have zero analyzed counts because those measures were not applicable to that arm. | Posted | Count of Participants | Participants | Day 28 |
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Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | 21mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day] | 0 | 16 | 0 | 16 | 9 | 16 |
| EG001 | Arm B | 21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 & [up to 30 per day] | 0 | 15 | 0 | 15 | 13 | 15 |
| EG002 | Arm C | 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day] | 0 | 15 | 0 | 15 | 10 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Irritation of nose, throat, or eyes | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Difficulty sleeping | Psychiatric disorders | Systematic Assessment |
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| Vivid dreams | Psychiatric disorders | Systematic Assessment |
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| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headaches | Nervous system disorders | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda M. Palmer, PhD | Medical University of South Carolina | 843-792-1413 | palmeram@musc.edu |
| Oct 17, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2023 | Oct 19, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| High |
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| Completed Day 28 Survey |
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| Completed >=80% of Daily Surveys |
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