Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-25 @ 1:58 AM
Study NCT ID:
NCT05644002
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2022-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Puff Biofeedback to Reduce Smoking Reinforcement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tml124@psych.rutgers.edu', 'phone': '848-445-2090', 'title': 'Dr. Teresa Leyro', 'organization': 'Rutgers, the State University of New Jersey'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline (Visit 0; virtual preliminary eligibility assessment session), Visit 1, and Visit 2 (within four weeks from Visit 0).', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cigarette Purchase Task- Omax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.84', 'spread': '23.96', 'groupId': 'OG000'}, {'value': '18.80', 'spread': '21.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.71', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.06', 'ciLowerLimit': '-9.09', 'ciUpperLimit': '13.21', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\<.05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.369', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction Omax between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees freedom = 66'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '.09', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Omax, which is the number of cigarettes the individual endorses that they would purchase at the peak expenditure for a cigarette (i.e., highest endorsed US dollar per cigarette cost; Pmax).', 'unitOfMeasure': 'cigarettes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits. Four participants randomized randomized to the PTBT condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, resulting in n=76 participants. An additional n=8 were excluded from these analyses due to invalid cigarette purchase task data resulting in a total of n=68 participants.'}, {'type': 'PRIMARY', 'title': 'Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.02', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '5.27', 'spread': '1.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.530', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.251', 'ciLowerLimit': '-.543', 'ciUpperLimit': '1.046', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\<.05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.631', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees freedom = 73'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '.14', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ cigarette satisfaction between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.', 'description': 'The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes liking, or cigarette satisfaction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective smoking satisfaction. Scores on the mCEQ cigarette satisfaction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits, Four participants randomized to the PTBT condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, and an additional one participant was excluded from this analysis due to invalid mCEQ data, resulting in a total of n=75 participants.'}, {'type': 'PRIMARY', 'title': 'Cigarette Purchase Task - Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.86', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '14.75', 'spread': '8.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.889', 'ciLowerLimit': '-3.149', 'ciUpperLimit': '4.927', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress intensity between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\<.05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.439', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction intensity between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees of freedom = 66'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.11', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction intensity between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is intensity, which is the number of cigarettes consumed at zero cost.', 'unitOfMeasure': 'cigarettes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits. Four participants randomized randomized to the PTBT condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, resulting in n=76 participants. An additional n=8 were excluded from these analyses due to invalid cigarette purchase task data resulting in a total of n=68 participants.'}, {'type': 'PRIMARY', 'title': 'Cigarette Purchase Task- Pmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.07', 'spread': '9.93', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '8.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.698', 'ciLowerLimit': '-5.443', 'ciUpperLimit': '4.046', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\<.05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.294', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction Pmax between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees freedom = 66'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.071', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Pmax, which is the price at maximum expenditure for a cigarette.', 'unitOfMeasure': 'US dollars per cigarette', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits. Four participants randomized randomized to the PTBT condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, resulting in n=76 participants. An additional n=8 were excluded from these analyses due to invalid cigarette purchase task data resulting in a total of n=68 participants.'}, {'type': 'PRIMARY', 'title': 'Cigarette Purchase Task- Breakpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.85', 'spread': '11.82', 'groupId': 'OG000'}, {'value': '8.50', 'spread': '11.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.354', 'ciLowerLimit': '-6.009', 'ciUpperLimit': '5.300', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\<.05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.125', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction breakpoint between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees of freedom = 66'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.03', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the breakpoint, which is the cost whereby consumption is suppressed to zero.', 'unitOfMeasure': 'US dollars per cigarette', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits. Four participants randomized randomized to the PTBT condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, resulting in n=76 participants. An additional n=8 were excluded from these analyses due to invalid cigarette purchase task data resulting in a total of n=68 participants.'}, {'type': 'PRIMARY', 'title': 'Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.692', 'spread': '1.575', 'groupId': 'OG000'}, {'value': '4.944', 'spread': '2.069', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.748', 'ciLowerLimit': '-1.601', 'ciUpperLimit': '.105', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\<.05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.750', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees freedom = 65.261'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.405', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ craving reduction between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.', 'description': 'The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes wanting, or cigarette craving reduction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective cigarette craving reduction. Scores on the mCEQ craving reduction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits, Four participants randomized to the PTBT condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, and an additional one participant was excluded from this analysis due to invalid mCEQ data, resulting in a total of n=75 participants.'}, {'type': 'PRIMARY', 'title': 'Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.144', 'spread': '1.768', 'groupId': 'OG000'}, {'value': '4.328', 'spread': '1.911', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.184', 'ciLowerLimit': '-.663', 'ciUpperLimit': '1.031', 'pValueComment': 'The threshold for statistical significance was p\\<.05', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\<.05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.184', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees freedom = 73'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '.099', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ psychological reward between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.', 'description': 'The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes learning, or psychological reward. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective psychological reward. Scores on the mCEQ psychological reward subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits, Four participants randomized to the PTBT condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, and an additional one participant was excluded from this analysis due to invalid mCEQ data, resulting in a total of n=75 participants.'}, {'type': 'SECONDARY', 'title': 'Changes in Cardiac Vagal Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.916', 'spread': '1.380', 'groupId': 'OG000'}, {'value': '4.778', 'spread': '1.506', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.026', 'ciLowerLimit': '-.358', 'ciUpperLimit': '.507', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress-induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrhythmia at step 1 of the model.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Coding: Control=0, PTBT=1.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.345', 'estimateComment': 'Condition (0=control; 1=PTBT)', 'groupDescription': 'A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrythmia at step 1 of the model.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees freedom = (2, 73)'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.', 'description': 'Beat-to-beat electrocardiograph and continuous respiration data were acquired using Thought Technology during the adaptation period and stress-precipitated smoking period. The data were and cleaned and scored using Mindware. Using Mindware, the IBI series is transformed to a heart period time series and then a heart power spectrum that is tapered using a Hamming window and finally a Fast Fourier Transform. Respiration data are similarly transformed using a Fast Fourier Transform to obtain a respiration power spectrum, and can be used to confirm the validity of the heart power spectrum data. Respiratory sinus arrhythmia is defined as variability in heart rate occurring in the high-frequency range, defined as 0.1 to 0.15 Hz corresponding with a respiratory rate between nine and 24 breaths per minute.', 'unitOfMeasure': 'milliseconds squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits. Four participants randomized to the PTBT condition were removed due to being \\<80% adherent to the training, resulting in n=76 participants.'}, {'type': 'SECONDARY', 'title': 'Puff Topography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'OG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.543', 'ciLowerLimit': '-.772', 'ciUpperLimit': '-.314', 'pValueComment': 'The threshold for statistical significance was p\\<.05.', 'groupDescription': 'An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Levene's test for equal variances was used. If significance is \\< .05, equal variances are not assumed and reported results are adjusted accordingly."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 't-statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.739', 'groupDescription': 'An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'degrees freedom = 66.03'}, {'groupIds': ['OG000', 'OG001'], 'paramType': "Hedge's g", 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.05', 'groupDescription': 'An independent-samples t-test was conducted to examine differences in post-stress-induction average puff duration between the PTBT and Control conditions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.', 'description': 'Puff topography indices will be objectively measured with the CReSS micro (Plowshare Technologies, Borgwaldt KC, Inc), a hand-held device that has a sterilized flow meter mouthpiece that is connected to a pressure transducer, which converts pressure into a digital signal that is sampled at 1,000Hz. Average Puff duration (sec) will be used to assess mechanism engagement from PTBT.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits. Four participants randomized to the PTBT (active) condition were removed due to being \\<80% adherent to the breathing/puff intervention prescribed, resulting in n=76 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'FG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Finished Visit 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Began Visit 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from the greater Rutgers, New Brunswick community via posters in the local community and online advertisements. The first participant was enrolled on March 21, 2022, and the last participant was enrolled on September 8th 2023', 'preAssignmentDetails': 'The study involved one virtual session (Visit 0) at which preliminary eligibility was determined. 154 individuals consented at this virtual session. 90 participants were preliminarily eligible, and arrived at the subsequent first in person visit. 6 individuals were found to be ineligible at this session (e.g., biochemical verification of smoking status through expired carbon monoxide). In total 84 individuals were randomized to one of the two conditions in Visit 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.\n\nControl: Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'BG001', 'title': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.\n\nPuff Topography Biofeedback Training: Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.025', 'spread': '7.427', 'groupId': 'BG000'}, {'value': '40.950', 'spread': '9.367', 'groupId': 'BG001'}, {'value': '40.988', 'spread': '8.399', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '68', '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': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who consented, were eligible, enrolled, were randomized, and completed both study visits.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-02', 'size': 742998, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-10T12:55', 'hasProtocol': True}, {'date': '2023-03-29', 'size': 6239638, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-02T17:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2022-07-12', 'resultsFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-13', 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cigarette Purchase Task- Omax', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Omax, which is the number of cigarettes the individual endorses that they would purchase at the peak expenditure for a cigarette (i.e., highest endorsed US dollar per cigarette cost; Pmax).'}, {'measure': 'Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.', 'description': 'The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes liking, or cigarette satisfaction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective smoking satisfaction. Scores on the mCEQ cigarette satisfaction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.'}, {'measure': 'Cigarette Purchase Task - Intensity', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is intensity, which is the number of cigarettes consumed at zero cost.'}, {'measure': 'Cigarette Purchase Task- Pmax', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Pmax, which is the price at maximum expenditure for a cigarette.'}, {'measure': 'Cigarette Purchase Task- Breakpoint', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.', 'description': 'The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the breakpoint, which is the cost whereby consumption is suppressed to zero.'}, {'measure': 'Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.', 'description': 'The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes wanting, or cigarette craving reduction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective cigarette craving reduction. Scores on the mCEQ craving reduction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.'}, {'measure': 'Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale', 'timeFrame': 'Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.', 'description': 'The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes learning, or psychological reward. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective psychological reward. Scores on the mCEQ psychological reward subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.'}], 'secondaryOutcomes': [{'measure': 'Changes in Cardiac Vagal Control', 'timeFrame': 'Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.', 'description': 'Beat-to-beat electrocardiograph and continuous respiration data were acquired using Thought Technology during the adaptation period and stress-precipitated smoking period. The data were and cleaned and scored using Mindware. Using Mindware, the IBI series is transformed to a heart period time series and then a heart power spectrum that is tapered using a Hamming window and finally a Fast Fourier Transform. Respiration data are similarly transformed using a Fast Fourier Transform to obtain a respiration power spectrum, and can be used to confirm the validity of the heart power spectrum data. Respiratory sinus arrhythmia is defined as variability in heart rate occurring in the high-frequency range, defined as 0.1 to 0.15 Hz corresponding with a respiratory rate between nine and 24 breaths per minute.'}, {'measure': 'Puff Topography', 'timeFrame': 'Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.', 'description': 'Puff topography indices will be objectively measured with the CReSS micro (Plowshare Technologies, Borgwaldt KC, Inc), a hand-held device that has a sterilized flow meter mouthpiece that is connected to a pressure transducer, which converts pressure into a digital signal that is sampled at 1,000Hz. Average Puff duration (sec) will be used to assess mechanism engagement from PTBT.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking', 'Cigarette', 'Stress', 'Distress'], 'conditions': ['Cigarette Smoking']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effects of a novel bio-behavioral paradigm, entitled, Puff Topography Biofeedback Training, compared to a control condition, in reducing stress-induced smoking reinforcement.', 'detailedDescription': 'Smokers with emotional distress are particularly vulnerable to smoking reinforcement due to various biopsychological factors that contribute to deficits in emotion regulation and heightened reward processing, which undermine cessation efforts. Differences in puffing behavior may correspond with changes in cardiorespiratory parameters that may promote self-regulation and reduce craving.\n\nThis study is a between-subjects experimental test of Puff Topography Biofeedback Training (PTBT) and its ability to modify puff topography and cardiorespiratory activity during stress-precipitated smoking, and in turn, reduce acute smoking reinforcement.\n\nParticipants will be randomized to either PTBT or a Control condition and will complete two smoking trials on two successive days. The first smoking trial (Visit 1) will allow participants to gain familiarity with the task. The second smoking trial (Visit 2) will be completed following acute laboratory stress induction (stress-precipitated smoking trial).\n\nThe primary study aims are to test the effect of PTBT vs. Control as assessed via acute changes in stress-precipitated smoking reinforcement and changes in puffing behavior and cardiorespiratory parameters.The results of this high pre-intervention study could inform the subsequent development of a novel intervention strategy for improving quit outcomes in a treatment-resistant population.\n\nThe primary study aims are to test the effect of PTBT vs. Control in terms of: (a) objective puff topography parameters; (b) subjective reinforcement; and (c) whether physiological indices reflective of smoking reinforcement differ between conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-55\n* Daily smoking ≥ 8 cigarettes/day verified by carbon monoxide analysis of breath sample ≥ 8 ppm\n* Smoking within 30 minutes of waking\n* English fluency.\n\nExclusion Criteria:\n\n* Current smoking cessation treatment\n* Past-month reduction of cigarettes/day by ≥50%\n* Moderate or severe non-nicotine substance use disorder\n* Past-year psychiatric instability (e.g., psychosis, mania)\n* Severe visual, hearing, or cognitive impairments\n* Medical condition that could impact stress reactivity or physiology\n* Current regular use of medication that could affect cardiorespiratory function (e.g., beta blockers, benzodiazepines; note-use of SSRIs/SNRIs is permitted if dose is stable ≥ 6 wks).'}, 'identificationModule': {'nctId': 'NCT05644002', 'briefTitle': 'Puff Biofeedback to Reduce Smoking Reinforcement', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'A Puff Topography Biofeedback Paradigm to Reduce Stress-Precipitated Smoking Reinforcement', 'orgStudyIdInfo': {'id': 'Pro2020000645'}, 'secondaryIdInfos': [{'id': 'R21DA052723', 'link': 'https://reporter.nih.gov/quickSearch/R21DA052723', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Puff Topography Biofeedback Training (PTBT)', 'description': 'In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.', 'interventionNames': ['Behavioral: Puff Topography Biofeedback Training']}], 'interventions': [{'name': 'Puff Topography Biofeedback Training', 'type': 'BEHAVIORAL', 'description': 'Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.', 'armGroupLabels': ['Puff Topography Biofeedback Training (PTBT)']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'otherNames': ['Attention Control'], 'description': 'Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes.\n\nVisit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers. The State University of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Teresa Leyro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}, {'name': 'Samantha Farris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication of primary study aims. Ending 5 years following article publication', 'ipdSharing': 'YES', 'description': 'Participant data that underlie the primary study aims after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically and theoretically sound proposal that is not redundant with the primary aims or findings already reported'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Teresa M. Leyro, Ph.D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}