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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA232516-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This phase 3 randomized controlled trial will test Metabolism-Informed Smoking Treatment (MIST), a precision approach to smoking treatment that biologically tailors medication selection to nicotine metabolism.
This is a randomized controlled trial to compare effects of MIST versus usual care (UC) interventions on the outcomes below.
Objectives:
Exploratory Objective:
- Longitudinal assessment of health care utilization visits (ER and hospitalization) for 12 months following hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIST (Metabolism-Informed Smoking Treatment) | Experimental | At hospital discharge, participants randomized to the MIST precision care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescriptions will be informed by nicotine metabolism (i.e., NMR result) such that faster metabolizers are prescribed varenicline and slower metabolizers are prescribed NRT. |
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| Usual Care | Active Comparator | At hospital discharge, participants randomized to the Usual Care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescription will not be informed by nicotine metabolism. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach. | Behavioral | Automated calls to assess smoking status, medication use, and additional support for quit attempt. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | 12 months | |
| Self-reported Medication Adherence Over the Past 7 Days | Participants taking any stop-smoking medications in past 7 days at 1 AND/OR 3 month surveys, also includes those who reported completing their course of medication at 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary Tindle, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450 | Nashville | Tennessee | 37203 | United States |
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5 participants were removed pre-randomization assignment by PI due to new information, discovered post-consent, indicating ineligibility.
Participants were recruited from a tertiary care hospital in the US Mid-South from November 17, 2020 to September 29, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | MIST (Metabolism-Informed Smoking Treatment) | All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR <0.31-NRT). |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
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| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2024 |
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| Nicotine Replacement Therapy | Drug | FDA-approved forms of nicotine replacement therapy for smoking cessation. |
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| Varenicline | Drug | FDA-approved smoking cessation medication. |
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| Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) | Other | Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine. |
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| 1, 3 months |
| Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription | Randomized participants who reported having an office visit with PCP or regular healthcare provider and reported receiving a medication recommendation or prescription (since study enrollment; 1, 3, 6, or 12 months). Some participants may have reported receiving more than 1 prescription over the course of the 12 months. | Up to 12 months after hospital discharge |
| FG001 | Guideline-Based Care | All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results. |
| 1-month Survey |
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| 3-month Survey |
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| 6-month Survey |
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| 12-month Survey |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MIST (Metabolism-Informed Smoking Treatment) | All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR <0.31-NRT). |
| BG001 | Guideline-Based Care | All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking). | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence | Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking). | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Self-reported Medication Adherence Over the Past 7 Days | Participants taking any stop-smoking medications in past 7 days at 1 AND/OR 3 month surveys, also includes those who reported completing their course of medication at 3 months. | Posted | Count of Participants | Participants | 1, 3 months |
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| Secondary | Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription | Randomized participants who reported having an office visit with PCP or regular healthcare provider and reported receiving a medication recommendation or prescription (since study enrollment; 1, 3, 6, or 12 months). Some participants may have reported receiving more than 1 prescription over the course of the 12 months. | Of note, 395 participants were missing for this measure due to report of not having an office visit and/or non-completion of all follow-up surveys. | Posted | Count of Participants | Participants | Up to 12 months after hospital discharge |
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12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
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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) |
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| EG000 | MIST (Metabolism-Informed Smoking Treatment) | All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR <0.31-NRT). | 16 | 294 | 140 | 294 | 84 | 294 |
| EG001 | Guideline-Based Care | All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results. | 17 | 307 | 131 | 307 | 90 | 307 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Anxiety (includes nervousness and panic attacks) | Psychiatric disorders | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | Systematic Assessment |
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| Emergency Medical Visit | Cardiac disorders | Systematic Assessment |
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| Emergency Medical Visit | Surgical and medical procedures | Systematic Assessment |
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| Medication Side Effects | Product Issues | Systematic Assessment |
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| Scheduled Medical Procedure | Cardiac disorders | Systematic Assessment |
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| Scheduled Medical Procedure | Investigations | Systematic Assessment |
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| Scheduled Medical Procedure | Surgical and medical procedures | Systematic Assessment |
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| Hospital Admission | Blood and lymphatic system disorders | Systematic Assessment |
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| Hospital Admission | Cardiac disorders | Systematic Assessment |
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| Hospital Admission | Endocrine disorders | Systematic Assessment |
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| Hospital Admission | Gastrointestinal disorders | Systematic Assessment |
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| Hospital Admission | General disorders | Systematic Assessment |
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| Hospital Admission | Hepatobiliary disorders | Systematic Assessment |
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| Hospital Admission | Infections and infestations | Systematic Assessment |
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| Hospital Admission | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hospital Admission | Investigations | Systematic Assessment |
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| Hospital Admission | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Hospital Admission | Renal and urinary disorders | Systematic Assessment |
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| Hospital Admission | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hospital Admission | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hospital Admission | Surgical and medical procedures | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Agitation and/or irritability | General disorders | Systematic Assessment |
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| Anxiety (includes nervousness and panic attacks) | Psychiatric disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Headaches | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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For context, this study began in 2020 at the start of the 2019 COVID pandemic, and was subject to delays associated with this global emergency. Additionally, in 2021 the study was impacted by the global recall of varenicline.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilary Tindle | Vanderbilt University Medical Center | (615) 875-9726 | hilary.tindle@vumc.org |
| May 19, 2025 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2024 | Dec 2, 2024 | ICF_001.pdf |
| ID | Term |
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| D012907 | Smoking |
| ID | Term |
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| D001519 | Behavior |
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| ID | Term |
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| D000095488 | Nicotine Replacement Therapy |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
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| >=65 years |
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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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| Unknown or Not Reported |
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