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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA052723 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
This 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.
Participants 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).
The 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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor. |
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| Puff Topography Biofeedback Training (PTBT) | Experimental | In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puff Topography Biofeedback Training | Behavioral | 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. Visit 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Purchase Task- Omax | 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). | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
| Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale | 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. | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days. |
| Cigarette Purchase Task - Intensity | 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. | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cardiac Vagal Control | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Leyro, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
| Samantha Farris, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers. The State University of New Jersey | New Brunswick | New Jersey | 08901 | United States |
Participant data that underlie the primary study aims after deidentification.
Immediately following publication of primary study aims. Ending 5 years following article publication
Researchers who provide a methodologically and theoretically sound proposal that is not redundant with the primary aims or findings already reported
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor. Control: 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. Visit 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. |
| FG001 | Puff Topography Biofeedback Training (PTBT) | In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm. Puff 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. Visit 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
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| Overall Study |
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Participants who consented, were eligible, enrolled, were randomized, and completed both study visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor. Control: 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. Visit 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cigarette Purchase Task- Omax | 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). | 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. | Posted | Mean | Standard Deviation | cigarettes | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
Baseline (Visit 0; virtual preliminary eligibility assessment session), Visit 1, and Visit 2 (within four weeks from Visit 0).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor. Control: 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. Visit 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Teresa Leyro | Rutgers, the State University of New Jersey | 848-445-2090 | tml124@psych.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2023 | Sep 10, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2023 | Feb 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Control | Behavioral | 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. Visit 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. |
|
|
| Cigarette Purchase Task- Pmax | 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. | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
| Cigarette Purchase Task- Breakpoint | 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. | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
| Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale | 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. | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days. |
| Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale | 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. | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days. |
| Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day. |
| Puff Topography | 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. | Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day. |
| BG001 | Puff Topography Biofeedback Training (PTBT) | In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm. Puff 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. Visit 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Control | In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor. Control: 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. Visit 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. |
| OG001 | Puff Topography Biofeedback Training (PTBT) | In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm. Puff 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. Visit 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. |
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| Primary | Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days. |
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| Primary | Cigarette Purchase Task - Intensity | 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. | 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. | Posted | Mean | Standard Deviation | cigarettes | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
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| Primary | Cigarette Purchase Task- Pmax | 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. | 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. | Posted | Mean | Standard Deviation | US dollars per cigarette | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
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| Primary | Cigarette Purchase Task- Breakpoint | 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. | 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. | Posted | Mean | Standard Deviation | US dollars per cigarette | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day. |
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|
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| Primary | Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days. |
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| Primary | Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days. |
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| Secondary | Changes in Cardiac Vagal Control | 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. | 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. | Posted | Mean | Standard Deviation | milliseconds squared | Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day. |
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| Secondary | Puff Topography | 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. | 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. | Posted | Mean | Standard Deviation | seconds | Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day. |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Puff Topography Biofeedback Training (PTBT) | In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm. Puff 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. Visit 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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| An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions. | t-test, 2 sided | degrees freedom = 73 | t-statistic | 0.631 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ cigarette satisfaction between the PTBT and Control conditions. | t-test, 2 sided | Hedge's g | .14 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress induction intensity between the PTBT and Control conditions. | t-test, 2 sided | degrees of freedom = 66 | t-statistic | 0.439 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress-induction intensity between the PTBT and Control conditions. | t-test, 2 sided | Hedge's g | -.11 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress induction Pmax between the PTBT and Control conditions. | t-test, 2 sided | degrees freedom = 66 | t-statistic | -0.294 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions. | t-test, 2 sided | Hedge's g | -.071 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress induction breakpoint between the PTBT and Control conditions. | t-test, 2 sided | degrees of freedom = 66 | t-statistic | -0.125 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions. | t-test, 2 sided | Hedge's g | -.03 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions. | t-test, 2 sided | degrees freedom = 65.261 | t-statistic | -1.750 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ craving reduction between the PTBT and Control conditions. | t-test, 2 sided | Hedge's g | -.405 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions. | t-test, 2 sided | degrees freedom = 73 | t-statistic | 0.184 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ psychological reward between the PTBT and Control conditions. | t-test, 2 sided | Hedge's g | .099 | 2-Sided | Other |
| 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. | Regression, Linear | degrees freedom = (2, 73) | t-statistic | 0.345 | 2-Sided | Condition (0=control; 1=PTBT) | Other |
| An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions. | t-test, 2 sided | degrees freedom = 66.03 | t-statistic | -4.739 | 2-Sided | Other |
| An independent-samples t-test was conducted to examine differences in post-stress-induction average puff duration between the PTBT and Control conditions. | t-test, 2 sided | Hedge's g | -1.05 | 2-Sided | Other |