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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941 | U.S. NIH Grant/Contract | View source | |
| CCC# 41042 | Other Identifier | ChristianaCHS |
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| Name | Class |
|---|---|
| University of Delaware | OTHER |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply offering an option of medications. The specific recommendation for a medication will be based on a test that measures how quickly a smoker breaks down, or metabolizes, nicotine.
Promising new evidence suggests that applying a precision pharmacotherapy approach based on the nicotine metabolite ration (NMR), a commercially available, genetically-informed marker of nicotine metabolism rate can significantly improve cessation outcomes. Evidence from multiple independent studies, including a recent randomized clinical trial (RCT), demonstrates that matching slow metabolizers of nicotine with the nicotine patch and fast metabolizers of nicotine with varenicline can maximize treatment response and minimize side effects. While encouraging, a critical gap in knowledge is how to best translate a precision pharmacotherapy approach into a hospital-based smoking cessation intervention and improve cessation rates for underserved smokers. Preliminary data suggest that personalized treatment recommendations may increase smoking cessation medication uptake and effectiveness. Thus, the scientific premise of this application is that integrating a precision pharmacotherapy approach into a hospital-based smoking cessation program will increase medication uptake and effectiveness, with particular relevance for smokers from underserved communities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Plan Option 1 (Standard Care) | Active Comparator | Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication. |
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| Treatment Plan Option 2 (Precision Pharmacotherapy) | Experimental | Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Behavioral | Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieve Smoking Cessation | Participants will report smoking status at the final assessment. Participants who self-report smoking cessation completed a carbon monoxide reading for biochemical confirmation of smoking status. The percentage of participants who achieve smoking cessation in each arm will be evaluated. | 4-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week) | Participants will report whether smoking cessation medication was used at the first week follow-up. The percentage of participants who used medication in each arm will be evaluated. | 1-week follow-up |
| Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D Siegel, Ph.D. | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen F. Graham Cancer Center & Research Institute | Newark | Delaware | 19713 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Plan Option 1 (Standard Care) | Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication. Standard Care: Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication. |
| FG001 | Treatment Plan Option 2 (Precision Pharmacotherapy) | Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication. Precision pharmacotherapy: Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Plan Option 1 (Standard Care) | Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication. Standard Care: Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication. |
| 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, Categorical | Count of 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 | Number of Participants Who Achieve Smoking Cessation | Participants will report smoking status at the final assessment. Participants who self-report smoking cessation completed a carbon monoxide reading for biochemical confirmation of smoking status. The percentage of participants who achieve smoking cessation in each arm will be evaluated. | Posted | Count of Participants | Participants | 4-week follow-up |
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General recruitment began in February 2022 - December 2022 (approximately 10 months). Patients who were enrolled received an initial baseline intake survey followed by appointments one week (Week 1) and four weeks (Week 4) after beginning their medication. Patient data for adverse events were collected during the patient's entire enrollment (approximately 6 weeks).
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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 | Treatment Plan Option 1 (Standard Care) | Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication. Standard Care: Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre-existing diabetes | Endocrine disorders | Systematic Assessment | Occurred on 8/15/22. Patient died from pre-existing, poorly controlled diabetes, that was determined to be unrelated to participation in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Event occurred on 9/20/22. Participant reported nausea from medication (varenicline), which is reported in more than 5% of people taking the medication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Siegel | Christiana Care Health System | 302-623-4500 | ssiegel@christianacare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2022 | Mar 6, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2020 | Mar 6, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2022 | Mar 6, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Patients will be randomized to the precision or standard care arms in a 1:1 ratio
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| Precision pharmacotherapy | Behavioral | Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication. |
|
Participants will report whether smoking cessation medication was used during 4 week follow up. The percentage of participants who used medication in each arm will be evaluated. |
| 4-week follow-up |
| Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile | Participants will report which smoking cessation medication, if any, was used. Medication usage will be classified as matching their NMR profile as follows: slower metabolizer = nicotine replacement therapy, faster metabolizer = varenicline. The percentage of participants who matched in each arm will be evaluated. | 1-week follow-up |
| BG001 | Treatment Plan Option 2 (Precision Pharmacotherapy) | Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication. Precision pharmacotherapy: Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Count of Active Smokers | Count of active smokers in each study arm, based on use of combustible cigarettes (self-reported as yes to active smoking), at the beginning of the study. Calculated to observe number of patients who successfully achieve smoking cessation (primary outcome). | Count of Participants | Participants |
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| Treatment Plan Option 2 (Precision Pharmacotherapy) |
Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication. Precision pharmacotherapy: Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication. |
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| Secondary | Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week) | Participants will report whether smoking cessation medication was used at the first week follow-up. The percentage of participants who used medication in each arm will be evaluated. | Posted | Count of Participants | Participants | 1-week follow-up |
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| Secondary | Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week) | Participants will report whether smoking cessation medication was used during 4 week follow up. The percentage of participants who used medication in each arm will be evaluated. | Posted | Count of Participants | Participants | 4-week follow-up |
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| Secondary | Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile | Participants will report which smoking cessation medication, if any, was used. Medication usage will be classified as matching their NMR profile as follows: slower metabolizer = nicotine replacement therapy, faster metabolizer = varenicline. The percentage of participants who matched in each arm will be evaluated. | Posted | Count of Participants | Participants | 1-week follow-up |
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| 0 |
| 17 |
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| 17 |
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| 17 |
| EG001 | Treatment Plan Option 2 (Precision Pharmacotherapy) | Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication. Precision pharmacotherapy: Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication. | 1 | 20 | 1 | 20 | 1 | 20 |
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