Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-18 @ 4:01 PM
Study NCT ID:
NCT03743532
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Darla-Kendzor@ouhsc.edu', 'phone': '(405) 271-7848', 'title': 'Dr. Darla E. Kendzor', 'organization': 'The University of Oklahoma Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combustible Cigarette Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post-switch date', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing cigarette smoking status were considered smoking.'}, {'type': 'PRIMARY', 'title': 'Combustible Cigarette Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching + Financial Incentives (EC+FI)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks post-quit/switch date', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing cigarette smoking status were considered smoking.'}, {'type': 'SECONDARY', 'title': 'Combustible Cigarette Cessation (Complete Case Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post-switch', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing smoking status were excluded from the analyses (i.e., complete case analysis).'}, {'type': 'SECONDARY', 'title': 'Combustible Cigarette Cessation (Complete Case Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks post-switch', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing smoking status data were excluded from the analyses (i.e., complete case analysis).'}, {'type': 'SECONDARY', 'title': 'Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '12.10', 'groupId': 'OG000'}, {'value': '-8.73', 'spread': '7.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post-switch', 'description': 'Change in expired CO (ppm) from baseline to 4 weeks post-switch-date.', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.57', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '-7.23', 'spread': '9.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 week post-switch', 'description': 'Change in expired CO (ppm) from baseline to 8 weeks post-switch-date', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Combustible Cigarette Smoking, Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '2.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post-switch', 'description': 'The total number of days of combustible cigarette smoking during the past week', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Combustible Cigarette Smoking, Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '3.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post-switch', 'description': 'The total number of days of combustible cigarette smoking during the past 7 days', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of E-cigarette Use, Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.64', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '2.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post-switch', 'description': 'The total number of days where e-cigarettes were used during the past 7 days', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of E-cigarette Use, Past 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching (EC) + Financial Incentives', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.15', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '3.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post-switch', 'description': 'The total number of days on which E-cigarettes were used during the past 7 days', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Follow-Up Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants were provided with an e-cigarette device and nicotine pods and advised to completely switch from combustible cigarettes to e-cigarettes. Although participants in the EC group did not earn incentives for combustible cigarette abstinence, they were yoked with a participant in the EC+FI group (described below), and they earned the same weekly incentive amount as their counterpart earned for combustible cigarette abstinence credited to a reloadable study credit card.\n\nE-cigarette Switching: Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.'}, {'id': 'OG001', 'title': 'E-Cigarette Switching + Financial Incentives (EC+FI)', 'description': 'Participants assigned to the EC+FI group received ECs and pods and were instructed to switch from combustible cigarettes to e-cigarettes as described above for the EC group. Participants also earned escalating financial incentives for self-reported and carbon-monoxide-verified combustible cigarette abstinence via credits to a reloadable study credit card. Participants who reported combustible cigarette use and/or had a CO level \\>6 ppm did not earn incentives that week, but could earn incentives at the next visit with the incentive value reset to the starting value.\n\nE-cigarette Switching: Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.\n\nFinancial Incentives: Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post-switch', 'description': 'The number of participants who completed the smoking status follow-up assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Follow-Up Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'OG001', 'title': 'E-cigarette Switching + Financial Incentives (EC+FI)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks post-switch', 'description': 'The number of participants who completed the smoking status follow-up assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'FG001', 'title': 'Financial Incentives + E-cigarette Switching', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'E-Cigarette Switching (EC)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes. They will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date.\n\nE-cigarette: Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.'}, {'id': 'BG001', 'title': 'E-cigarette Switching + Financial Incentives (EC+FI)', 'description': 'Participants will be asked to completely switch from cigarettes to e-cigarettes, and they will receive an e-cigarette device and pods during the first 4 weeks following a scheduled switch date. Participants will also receive weekly financial incentives for biochemically-verified cigarette abstinence during the first 4 weeks following the switch date.\n\nFinancial incentives + E-cigarette: Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], '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': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.30', 'spread': '10.98', 'groupId': 'BG000'}, {'value': '47.23', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '48.77', 'spread': '10.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Currently Experiencing Homelessness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarettes Smoked Per Day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.73', 'spread': '12.13', 'groupId': 'BG000'}, {'value': '16.28', 'spread': '11.08', 'groupId': 'BG001'}, {'value': '16.00', 'spread': '11.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of cigarettes smoked per day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant excluded from analyses because of out of range value (i.e., 2400 cigarettes per day).'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-11', 'size': 419652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-09T17:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2018-11-13', 'resultsFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-13', 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combustible Cigarette Cessation', 'timeFrame': '4 weeks post-switch date', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)'}, {'measure': 'Combustible Cigarette Cessation', 'timeFrame': '8 weeks post-quit/switch date', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)'}], 'secondaryOutcomes': [{'measure': 'Combustible Cigarette Cessation (Complete Case Analysis)', 'timeFrame': '4 weeks post-switch', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)'}, {'measure': 'Combustible Cigarette Cessation (Complete Case Analysis)', 'timeFrame': '8 weeks post-switch', 'description': 'Self-reported and Carbon monoxide-verified (\\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing excluded)'}, {'measure': 'Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline', 'timeFrame': '4 weeks post-switch', 'description': 'Change in expired CO (ppm) from baseline to 4 weeks post-switch-date.'}, {'measure': 'Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline', 'timeFrame': '8 week post-switch', 'description': 'Change in expired CO (ppm) from baseline to 8 weeks post-switch-date'}, {'measure': 'Days of Combustible Cigarette Smoking, Past 7 Days', 'timeFrame': '4 weeks post-switch', 'description': 'The total number of days of combustible cigarette smoking during the past week'}, {'measure': 'Days of Combustible Cigarette Smoking, Past 7 Days', 'timeFrame': '8 weeks post-switch', 'description': 'The total number of days of combustible cigarette smoking during the past 7 days'}, {'measure': 'Days of E-cigarette Use, Past 7 Days', 'timeFrame': '4 weeks post-switch', 'description': 'The total number of days where e-cigarettes were used during the past 7 days'}, {'measure': 'Days of E-cigarette Use, Past 7 Days', 'timeFrame': '8 weeks post-switch', 'description': 'The total number of days on which E-cigarettes were used during the past 7 days'}, {'measure': 'Follow-Up Completion', 'timeFrame': '4 weeks post-switch', 'description': 'The number of participants who completed the smoking status follow-up assessment.'}, {'measure': 'Follow-Up Completion', 'timeFrame': '8 weeks post-switch', 'description': 'The number of participants who completed the smoking status follow-up assessment'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Contingency management', 'Financial incentives', 'E-cigarettes', 'Homelessness'], 'conditions': ['Cigarette Smoking']}, 'referencesModule': {'references': [{'pmid': '36844157', 'type': 'BACKGROUND', 'citation': 'Boozary LK, Frank-Pearce SG, Alexander AC, Sifat MS, Kurien J, Waring JJC, Ehlke SJ, Businelle MS, Ahluwalia JS, Kendzor DE. Tobacco use characteristics, treatment preferences, and motivation to quit among adults accessing a day shelter in Oklahoma City. Drug Alcohol Depend Rep. 2022 Nov 5;5:100117. doi: 10.1016/j.dadr.2022.100117. eCollection 2022 Dec.'}, {'pmid': '39764385', 'type': 'RESULT', 'citation': 'Sifat MS, Alexander AC, Businelle MS, Frank-Pearce SG, Boozary LK, Wagener TL, Ahluwalia JS, Kendzor DE. E-Cigarette switching and financial incentives to promote combustible cigarette cessation among adults accessing shelter services: A pilot study. Drug Alcohol Depend Rep. 2024 Nov 6;13:100295. doi: 10.1016/j.dadr.2024.100295. eCollection 2024 Dec.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluated the feasibility and potential efficacy of 1) e-cigarette switching (EC) or 2) e-cigarette switching + financial incentives for combustible cigarette cessation (EC+FI)', 'detailedDescription': 'The current study examined the feasibility of e-cigarette switching and financial incentives contingent on combustible cigarette abstinence to promote combustible cigarette cessation among urban day shelter guests (N=60). A total of 60 adults who accessed the Homeless Alliance day shelter in Oklahoma City, OK were randomly assigned to 1 of 2 groups and followed weekly from 1 week prior to a scheduled EC switch date through 4 weeks post-switch date, with a final 8-week post-switch follow-up. The intervention groups were: 1) e-cigarette switching (EC) or 2) EC switching + small financial incentives for carbon monoxide (CO) verified combustible cigarette abstinence (FI + EC). The primary outcomes were self-reported combustible cigarette abstinence over the previous 7 days with carbon monoxide (CO)-verification at 4- and 8- weeks follow-up. Secondary outcomes included changes in CO from baseline, days of combustible cigarette smoking, and continued e-cigarette use. Other feasibility outcomes included study retention and perceptions of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. ≥21 years of age\n2. Expired CO level ≥8 ppm suggestive of current smoking\n3. reported smoking ≥5 cigarettes per day\n4. Willing and able to attend 8 study visits over a 10-week period\n5. Interested in switching from CCs to ECs\n6. Willing to abstain from smoking cannabis for the duration of the study\n7. Able to speak and understand English\n8. Demonstrated \\>6th grade English literacy by earning a score ≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF),\n9. Able to read a 3-sentence selection from the consent form\n10. Not pregnant, breastfeeding, or planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT03743532', 'acronym': 'EXCHANGE', 'briefTitle': 'E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'A Needs Survey of Urban Day Shelter Users and Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation: The Exchange Project', 'orgStudyIdInfo': {'id': '10124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-Cigarette Switching (EC)', 'description': 'Participants were provided with an e-cigarette device and nicotine pods and advised to completely switch from combustible cigarettes to e-cigarettes. Although participants in the EC group did not earn incentives for combustible cigarette abstinence, they were yoked with a participant in the EC+FI group (described below), and they earned the same weekly incentive amount as their counterpart earned for combustible cigarette abstinence credited to a reloadable study credit card.', 'interventionNames': ['Behavioral: E-cigarette Switching']}, {'type': 'EXPERIMENTAL', 'label': 'E-Cigarette Switching + Financial Incentives (EC+FI)', 'description': 'Participants assigned to the EC+FI group received ECs and pods and were instructed to switch from combustible cigarettes to e-cigarettes as described above for the EC group. Participants also earned escalating financial incentives for self-reported and carbon-monoxide-verified combustible cigarette abstinence via credits to a reloadable study credit card. Participants who reported combustible cigarette use and/or had a CO level \\>6 ppm did not earn incentives that week, but could earn incentives at the next visit with the incentive value reset to the starting value.', 'interventionNames': ['Behavioral: E-cigarette Switching', 'Behavioral: Financial Incentives']}], 'interventions': [{'name': 'E-cigarette Switching', 'type': 'BEHAVIORAL', 'otherNames': ['EC'], 'description': 'Participants provided with e-cigarette device and nicotine pods and advised to switch from combustible cigarettes to e-cigarettes.', 'armGroupLabels': ['E-Cigarette Switching (EC)', 'E-Cigarette Switching + Financial Incentives (EC+FI)']}, {'name': 'Financial Incentives', 'type': 'BEHAVIORAL', 'otherNames': ['FI'], 'description': 'Participants earned incentives for carbon monoxide-verified combustible cigarette abstinence.', 'armGroupLabels': ['E-Cigarette Switching + Financial Incentives (EC+FI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73106', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Homeless Alliance', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Darla E. Kendzor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}