Trial Outcomes & Findings for Puff Biofeedback to Reduce Smoking Reinforcement (NCT NCT05644002)
NCT ID: NCT05644002
Last Updated: 2025-02-24
Results Overview
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).
COMPLETED
NA
154 participants
Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
2025-02-24
Participant Flow
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
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
Finished Visit 1
|
41
|
43
|
|
Overall Study
Began Visit 2
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Puff Biofeedback to Reduce Smoking Reinforcement
Baseline characteristics by cohort
| Measure |
Control
n=40 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.025 years
STANDARD_DEVIATION 7.427 • n=5 Participants
|
40.950 years
STANDARD_DEVIATION 9.367 • n=7 Participants
|
40.988 years
STANDARD_DEVIATION 8.399 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.Population: 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.
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).
Outcome measures
| Measure |
Control
n=36 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=32 Participants
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.
|
|---|---|---|
|
Cigarette Purchase Task- Omax
|
18.84 cigarettes
Standard Deviation 23.96
|
18.80 cigarettes
Standard Deviation 21.81
|
PRIMARY outcome
Timeframe: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.Population: 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.
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.
Outcome measures
| Measure |
Control
n=39 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=36 Participants
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.
|
|---|---|---|
|
Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale
|
5.02 score on a scale
Standard Deviation 1.68
|
5.27 score on a scale
Standard Deviation 1.77
|
PRIMARY outcome
Timeframe: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.Population: 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.
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.
Outcome measures
| Measure |
Control
n=36 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=32 Participants
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.
|
|---|---|---|
|
Cigarette Purchase Task - Intensity
|
13.86 cigarettes
Standard Deviation 8.51
|
14.75 cigarettes
Standard Deviation 8.11
|
PRIMARY outcome
Timeframe: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.Population: 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.
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.
Outcome measures
| Measure |
Control
n=36 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=32 Participants
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.
|
|---|---|---|
|
Cigarette Purchase Task- Pmax
|
5.07 US dollars per cigarette
Standard Deviation 9.93
|
4.37 US dollars per cigarette
Standard Deviation 8.61
|
PRIMARY outcome
Timeframe: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.Population: 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.
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.
Outcome measures
| Measure |
Control
n=36 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=32 Participants
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.
|
|---|---|---|
|
Cigarette Purchase Task- Breakpoint
|
8.85 US dollars per cigarette
Standard Deviation 11.82
|
8.50 US dollars per cigarette
Standard Deviation 11.93
|
PRIMARY outcome
Timeframe: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.Population: 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.
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.
Outcome measures
| Measure |
Control
n=39 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=36 Participants
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.
|
|---|---|---|
|
Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale
|
5.692 units on a scale
Standard Deviation 1.575
|
4.944 units on a scale
Standard Deviation 2.069
|
PRIMARY outcome
Timeframe: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.Population: 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.
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.
Outcome measures
| Measure |
Control
n=39 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=36 Participants
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.
|
|---|---|---|
|
Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale
|
4.144 units on a scale
Standard Deviation 1.768
|
4.328 units on a scale
Standard Deviation 1.911
|
SECONDARY outcome
Timeframe: Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.Population: 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.
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.
Outcome measures
| Measure |
Control
n=40 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=36 Participants
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.
|
|---|---|---|
|
Changes in Cardiac Vagal Control
|
4.916 milliseconds squared
Standard Deviation 1.380
|
4.778 milliseconds squared
Standard Deviation 1.506
|
SECONDARY outcome
Timeframe: Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.Population: 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.
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.
Outcome measures
| Measure |
Control
n=40 Participants
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.
|
Puff Topography Biofeedback Training (PTBT)
n=36 Participants
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.
|
|---|---|---|
|
Puff Topography
|
2.05 seconds
Standard Deviation 0.61
|
1.51 seconds
Standard Deviation 0.38
|
Adverse Events
Control
Puff Topography Biofeedback Training (PTBT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Teresa Leyro
Rutgers, the State University of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place