Cigarette Smoking
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale | Second 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- Breakpoint | Second 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 Subscale | Second 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- Omax | Second 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 Subscale | Second 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 - Intensity | Second 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- Pmax | Second 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
| Measure | Time frame | Description |
|---|---|---|
| Puff Topography | Second 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 Control | Second 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
| Arm | Count |
|---|---|
| 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 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Puff Topography Biofeedback Training (PTBT) |
|---|---|---|---|
| Age, Continuous | 41.025 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 Participants | 12 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 68 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 28 Participants | 56 Participants | 28 Participants |
| Region of Enrollment United States | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Female | 18 Participants | 32 Participants | 14 Participants |
| Sex: Female, Male Male | 22 Participants | 48 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Cigarette Purchase Task- Breakpoint | 8.85 US dollars per cigarette | Standard Deviation 11.82 |
| Puff Topography Biofeedback Training (PTBT) | Cigarette Purchase Task- Breakpoint | 8.50 US dollars per cigarette | Standard Deviation 11.93 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Cigarette Purchase Task - Intensity | 13.86 cigarettes | Standard Deviation 8.51 |
| Puff Topography Biofeedback Training (PTBT) | Cigarette Purchase Task - Intensity | 14.75 cigarettes | Standard Deviation 8.11 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Cigarette Purchase Task- Omax | 18.84 cigarettes | Standard Deviation 23.96 |
| Puff Topography Biofeedback Training (PTBT) | Cigarette Purchase Task- Omax | 18.80 cigarettes | Standard Deviation 21.81 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Cigarette Purchase Task- Pmax | 5.07 US dollars per cigarette | Standard Deviation 9.93 |
| Puff Topography Biofeedback Training (PTBT) | Cigarette Purchase Task- Pmax | 4.37 US dollars per cigarette | Standard Deviation 8.61 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale | 5.02 score on a scale | Standard Deviation 1.68 |
| Puff Topography Biofeedback Training (PTBT) | Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale | 5.27 score on a scale | Standard Deviation 1.77 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale | 5.692 units on a scale | Standard Deviation 1.575 |
| Puff Topography Biofeedback Training (PTBT) | Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale | 4.944 units on a scale | Standard Deviation 2.069 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale | 4.144 units on a scale | Standard Deviation 1.768 |
| Puff Topography Biofeedback Training (PTBT) | Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale | 4.328 units on a scale | Standard Deviation 1.911 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Changes in Cardiac Vagal Control | 4.916 milliseconds squared | Standard Deviation 1.38 |
| Puff Topography Biofeedback Training (PTBT) | Changes in Cardiac Vagal Control | 4.778 milliseconds squared | Standard Deviation 1.506 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Puff Topography | 2.05 seconds | Standard Deviation 0.61 |
| Puff Topography Biofeedback Training (PTBT) | Puff Topography | 1.51 seconds | Standard Deviation 0.38 |