Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 6:26 AM
Study NCT ID:
NCT04590404
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2020-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metabolism Informed Smoking Treatment: The MIST RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}, {'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hilary.tindle@vumc.org', 'phone': '(615) 875-9726', 'title': 'Dr. Hilary Tindle', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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).', 'otherNumAtRisk': 294, 'deathsNumAtRisk': 294, 'otherNumAffected': 84, 'seriousNumAtRisk': 294, 'deathsNumAffected': 16, 'seriousNumAffected': 140}, {'id': 'EG001', 'title': 'Guideline-Based Care', 'description': '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.', 'otherNumAtRisk': 307, 'deathsNumAtRisk': 307, 'otherNumAffected': 90, 'seriousNumAtRisk': 307, 'deathsNumAffected': 17, 'seriousNumAffected': 131}], 'otherEvents': [{'term': 'Agitation and/or irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety (includes nervousness and panic attacks)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anxiety (includes nervousness and panic attacks)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Medical Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Medical Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 159, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 175, 'numAffected': 76}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Medication Side Effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scheduled Medical Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scheduled Medical Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scheduled Medical Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 36, 'numAffected': 31}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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).'}, {'id': 'OG001', 'title': 'Guideline-Based Care', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.461', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.82', 'groupDescription': 'The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 6 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \\& plan to quit after discharge'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking).'}, {'type': 'SECONDARY', 'title': 'Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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).'}, {'id': 'OG001', 'title': 'Guideline-Based Care', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.54', 'pValueComment': 'Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \\& plan to quit after discharge', 'groupDescription': 'The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 12 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking).'}, {'type': 'SECONDARY', 'title': 'Self-reported Medication Adherence Over the Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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).'}, {'id': 'OG001', 'title': 'Guideline-Based Care', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 3 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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).'}, {'id': 'OG001', 'title': 'Guideline-Based Care', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months after hospital discharge', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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).'}, {'id': 'FG001', 'title': 'Guideline-Based Care', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': '1-month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '271'}]}, {'type': '3-month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '264'}]}, {'type': '6-month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}, {'groupId': 'FG001', 'numSubjects': '261'}]}, {'type': '12-month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from a tertiary care hospital in the US Mid-South from November 17, 2020 to September 29, 2023.', 'preAssignmentDetails': '5 participants were removed pre-randomization assignment by PI due to new information, discovered post-consent, indicating ineligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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).'}, {'id': 'BG001', 'title': 'Guideline-Based Care', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.88', 'spread': '11.60', 'groupId': 'BG000'}, {'value': '56.45', 'spread': '11.53', 'groupId': 'BG001'}, {'value': '56.17', 'spread': '11.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '587', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-26', 'size': 561898, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-19T17:42', 'hasProtocol': True}, {'date': '2024-09-16', 'size': 672559, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-02T10:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2020-10-05', 'resultsFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-05-20', 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence', 'timeFrame': '12 months'}, {'measure': 'Self-reported Medication Adherence Over the Past 7 Days', 'timeFrame': '1, 3 months', 'description': '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.'}, {'measure': 'Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription', 'timeFrame': 'Up to 12 months after hospital discharge', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a randomized controlled trial to compare effects of MIST versus usual care (UC) interventions on the outcomes below.\n\nObjectives:\n\n* Abstinence as defined by biochemically-verified self-reported 7-day point prevalence abstinence at 6 m (1° study outcome) and 12 m (2° outcome).\n* Clinical practice implementation as measured by participant self-reported medication adherence at months 1 and 3, self-reported receipt of prescription for smoking cessation medication after hospital discharge, and whether the prescription was tailored to the NMR result.\n\nExploratory Objective:\n\n\\- Longitudinal assessment of health care utilization visits (ER and hospitalization) for 12 months following hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be 18 years or older\n* be enrolled in an insurance plan that supports prescription coverage for smoking cessation medication (such as Medicare part D, Medicaid, or private insurance) to facilitate bedside delivery of medications prior to hospital discharge\n* have a regular provider/PCP\n* agree to quit or try to quit smoking upon hospital discharge\n* be a daily smoker when smoking normally during the month prior to entering the hospital\n* be medically eligible to use varenicline\n* be medically eligible to use nicotine replacement therapy\n* have received discharge medication recommendations from a tobacco counselor\n* agree to take smoking cessation medication (i.e., varenicline OR nicotine replacement therapy) home and consider using it\n* have a cell phone or landline that can be reached directly (i.e., without transfer)\n* have a permanent address where they live and can receive mail\n* estimated life expectancy of at least one year or greater\n\nExclusion Criteria:\n\n* insufficient time to perform and complete the enrollment process\n* barrier to effective communication (including low English proficiency)\n* not cognitively able to participate in the study\n* too ill, on hospice, or physically unable to participate in the follow-up process\n* previously completed the MIST study or is currently enrolled in a quit smoking study that involves a medication-based treatment\n* estimated life expectancy of less than one year'}, 'identificationModule': {'nctId': 'NCT04590404', 'briefTitle': 'Metabolism Informed Smoking Treatment: The MIST RCT', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT', 'orgStudyIdInfo': {'id': 'VICC THO 2046'}, 'secondaryIdInfos': [{'id': '5R01CA232516-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA232516-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIST (Metabolism-Informed Smoking Treatment)', 'description': '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.', 'interventionNames': ['Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.', 'Drug: Nicotine Replacement Therapy', 'Drug: Varenicline', 'Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': '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.', 'interventionNames': ['Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.', 'Drug: Nicotine Replacement Therapy', 'Drug: Varenicline']}], 'interventions': [{'name': 'Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.', 'type': 'BEHAVIORAL', 'description': 'Automated calls to assess smoking status, medication use, and additional support for quit attempt.', 'armGroupLabels': ['MIST (Metabolism-Informed Smoking Treatment)', 'Usual Care']}, {'name': 'Nicotine Replacement Therapy', 'type': 'DRUG', 'description': 'FDA-approved forms of nicotine replacement therapy for smoking cessation.', 'armGroupLabels': ['MIST (Metabolism-Informed Smoking Treatment)', 'Usual Care']}, {'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'FDA-approved smoking cessation medication.', 'armGroupLabels': ['MIST (Metabolism-Informed Smoking Treatment)', 'Usual Care']}, {'name': 'Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)', 'type': 'OTHER', 'description': 'Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.', 'armGroupLabels': ['MIST (Metabolism-Informed Smoking Treatment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Hilary Tindle, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Hilary Tindle', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}