Puff Biofeedback to Reduce Smoking Reinforcement

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

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Behavioral: Control; Behavioral: Puff Topography Biofeedback Training

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers. The State University of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.	Behavioral: 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.; Other Names: Attention Control
Experimental: Puff Topography Biofeedback Training (PTBT); In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette Purchase Task- Omax	The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Omax, which is the number of cigarettes the individual endorses that they would purchase at the peak expenditure for a cigarette (i.e., highest endorsed US dollar per cigarette cost; Pmax).	Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale	The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes liking, or cigarette satisfaction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective smoking satisfaction. Scores on the mCEQ cigarette satisfaction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.	Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
Cigarette Purchase Task - Intensity	The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is intensity, which is the number of cigarettes consumed at zero cost.	Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
Cigarette Purchase Task- Pmax	The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the Pmax, which is the price at maximum expenditure for a cigarette.	Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
Cigarette Purchase Task- Breakpoint	The Short-Cigarette Purchase Task (CPT) will be used to assess smoking reinforcement in response to stress-precipitated smoking. The CPT is based on progressive-ratio operant schedules wherein participants self-report their hypothetical cigarette consumption at various levels of price. Hypothetical purchasing will be based on the "last cigarette smoked". Five key behavioral economic indices of demand can be obtained from the CPT. One index reported here is the breakpoint, which is the cost whereby consumption is suppressed to zero.	Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale	The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes wanting, or cigarette craving reduction. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective cigarette craving reduction. Scores on the mCEQ craving reduction subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.	Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale	The Modified Cigarette Evaluation Questionnaire (mCEQ) will be used to assess subjective smoking reinforcement. The mCEQ is a self-report measure that assesses how respondents feel about the "last cigarette smoked" with three subscales. One subscale indexes learning, or psychological reward. Score on this subscale range from 1 to 7, with higher scores reflecting greater subjective psychological reward. Scores on the mCEQ psychological reward subscale administered post stress-precipitated smoking, during Visit 2, will be compared between conditions.	Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Cardiac Vagal Control	Beat-to-beat electrocardiograph and continuous respiration data were acquired using Thought Technology during the adaptation period and stress-precipitated smoking period. The data were and cleaned and scored using Mindware. Using Mindware, the IBI series is transformed to a heart period time series and then a heart power spectrum that is tapered using a Hamming window and finally a Fast Fourier Transform. Respiration data are similarly transformed using a Fast Fourier Transform to obtain a respiration power spectrum, and can be used to confirm the validity of the heart power spectrum data. Respiratory sinus arrhythmia is defined as variability in heart rate occurring in the high-frequency range, defined as 0.1 to 0.15 Hz corresponding with a respiratory rate between nine and 24 breaths per minute.	Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.
Puff Topography	Puff topography indices will be objectively measured with the CReSS micro (Plowshare Technologies, Borgwaldt KC, Inc), a hand-held device that has a sterilized flow meter mouthpiece that is connected to a pressure transducer, which converts pressure into a digital signal that is sampled at 1,000Hz. Average Puff duration (sec) will be used to assess mechanism engagement from PTBT.	Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Teresa Leyro, PhD, Rutgers, The State University of New Jersey; Principal Investigator: Samantha Farris, PhD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Stress; Smoking; Cigarette; Distress
• Other Study ID Numbers: Pro2020000645; R21DA052723 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data that underlie the primary study aims after deidentification.
• IPD Sharing Time Frame: Immediately following publication of primary study aims. Ending 5 years following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically and theoretically sound proposal that is not redundant with the primary aims or findings already reported
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes