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Puff Biofeedback to Reduce Smoking Reinforcement

A Puff Topography Biofeedback Paradigm to Reduce Stress-Precipitated Smoking Reinforcement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05644002
Enrollment
154
Registered
2022-12-09
Start date
2022-03-21
Completion date
2023-09-13
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

Keywords

Smoking, Cigarette, Stress, Distress

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPuff 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.

BEHAVIORALControl

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-55 * Daily smoking ≥ 8 cigarettes/day verified by carbon monoxide analysis of breath sample ≥ 8 ppm * Smoking within 30 minutes of waking * English fluency.

Exclusion criteria

* Current smoking cessation treatment * Past-month reduction of cigarettes/day by ≥50% * Moderate or severe non-nicotine substance use disorder * Past-year psychiatric instability (e.g., psychosis, mania) * Severe visual, hearing, or cognitive impairments * Medical condition that could impact stress reactivity or physiology * 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).

Design outcomes

Primary

MeasureTime frameDescription
Modified Cigarette Evaluation Questionnaire - Psychological Reward SubscaleSecond Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.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.
Cigarette Purchase Task- BreakpointSecond Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.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.
Modified Cigarette Evaluation Questionnaire - Craving Reduction SubscaleSecond Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.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.
Cigarette Purchase Task- OmaxSecond Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.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).
Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction SubscaleSecond Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.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.
Cigarette Purchase Task - IntensitySecond Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.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.
Cigarette Purchase Task- PmaxSecond Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.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.

Secondary

MeasureTime frameDescription
Puff TopographySecond Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.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.
Changes in Cardiac Vagal ControlSecond Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.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.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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 by arm

ArmCount
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.
40
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.
40
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up12
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicControlTotalPuff Topography Biofeedback Training (PTBT)
Age, Continuous41.025 years
STANDARD_DEVIATION 7.427
40.988 years
STANDARD_DEVIATION 8.399
40.950 years
STANDARD_DEVIATION 9.367
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants12 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants68 Participants30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
9 Participants18 Participants9 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
White
28 Participants56 Participants28 Participants
Region of Enrollment
United States
40 Participants80 Participants40 Participants
Sex: Female, Male
Female
18 Participants32 Participants14 Participants
Sex: Female, Male
Male
22 Participants48 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 40
other
Total, other adverse events
0 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 40

Outcome results

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlCigarette Purchase Task- Breakpoint8.85 US dollars per cigaretteStandard Deviation 11.82
Puff Topography Biofeedback Training (PTBT)Cigarette Purchase Task- Breakpoint8.50 US dollars per cigaretteStandard Deviation 11.93
Comparison: An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.p-value: 0.995% CI: [-6.009, 5.3]t-test, 2 sided
Comparison: 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
Comparison: 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
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlCigarette Purchase Task - Intensity13.86 cigarettesStandard Deviation 8.51
Puff Topography Biofeedback Training (PTBT)Cigarette Purchase Task - Intensity14.75 cigarettesStandard Deviation 8.11
Comparison: An independent-samples t-test was conducted to examine differences in post-stress intensity between the PTBT and Control conditions.p-value: 0.6695% CI: [-3.149, 4.927]t-test, 2 sided
Comparison: 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
Comparison: 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
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).

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlCigarette Purchase Task- Omax18.84 cigarettesStandard Deviation 23.96
Puff Topography Biofeedback Training (PTBT)Cigarette Purchase Task- Omax18.80 cigarettesStandard Deviation 21.81
Comparison: An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.p-value: 0.7195% CI: [-9.09, 13.21]t-test, 2 sided
Comparison: An independent-samples t-test was conducted to examine differences in post-stress induction Omax between the PTBT and Control conditions.t-test, 2 sided
Comparison: An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.t-test, 2 sided
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlCigarette Purchase Task- Pmax5.07 US dollars per cigaretteStandard Deviation 9.93
Puff Topography Biofeedback Training (PTBT)Cigarette Purchase Task- Pmax4.37 US dollars per cigaretteStandard Deviation 8.61
Comparison: An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.p-value: 0.7795% CI: [-5.443, 4.046]t-test, 2 sided
Comparison: 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
Comparison: 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
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlModified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale5.02 score on a scaleStandard Deviation 1.68
Puff Topography Biofeedback Training (PTBT)Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale5.27 score on a scaleStandard Deviation 1.77
Comparison: An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.p-value: 0.5395% CI: [-0.543, 1.046]t-test, 2 sided
Comparison: 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
Comparison: 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
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlModified Cigarette Evaluation Questionnaire - Craving Reduction Subscale5.692 units on a scaleStandard Deviation 1.575
Puff Topography Biofeedback Training (PTBT)Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale4.944 units on a scaleStandard Deviation 2.069
Comparison: An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.p-value: 0.0995% CI: [-1.601, 0.105]t-test, 2 sided
Comparison: 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
Comparison: 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
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlModified Cigarette Evaluation Questionnaire - Psychological Reward Subscale4.144 units on a scaleStandard Deviation 1.768
Puff Topography Biofeedback Training (PTBT)Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale4.328 units on a scaleStandard Deviation 1.911
Comparison: An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.p-value: 0.66695% CI: [-0.663, 1.031]t-test, 2 sided
Comparison: 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
Comparison: 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
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlChanges in Cardiac Vagal Control4.916 milliseconds squaredStandard Deviation 1.38
Puff Topography Biofeedback Training (PTBT)Changes in Cardiac Vagal Control4.778 milliseconds squaredStandard Deviation 1.506
Comparison: 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.p-value: 0.7395% CI: [-0.358, 0.507]Regression, Linear
Comparison: 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
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlPuff Topography2.05 secondsStandard Deviation 0.61
Puff Topography Biofeedback Training (PTBT)Puff Topography1.51 secondsStandard Deviation 0.38
Comparison: An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.p-value: 0.00195% CI: [-0.772, -0.314]t-test, 2 sided
Comparison: 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
Comparison: 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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026