Puff Biofeedback to Reduce Smoking Reinforcement

NCT05644002 | Completed Results

• 2 other identifiers: Pro2020000645R21DA052723
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking

Keywords

Smoking; Cigarette; Stress; Distress

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Changes in Cardiac Vagal Control

  Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.

• Puff Topography

  Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.

Study Arms (2)

Control

SHAM COMPARATOR

In this condition, participants are instructed to smoke as usual while attending to control stimuli presented to them on a computer monitor.

Behavioral: Control

Puff Topography Biofeedback Training (PTBT)

EXPERIMENTAL

In this condition, participants are provided instructions on how to puff their cigarette via a computer-assisted paradigm.

Behavioral: Puff Topography Biofeedback Training

Interventions

Puff Topography Biofeedback Training BEHAVIORAL

Visit 1: Participants will be asked to smoke their usual brand cigarette using the CReSS smoking topography device. Participants will be instructed on how to follow visual and auditory puffing prompts provided to them by a computer program in order to control puffing behavior for a duration of five minutes. Visit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.

Puff Topography Biofeedback Training (PTBT)

Control BEHAVIORAL

Visit 1: Participants will be instructed to smoke their usual brand cigarette using the CReSS smoking topography device while passively viewing time-matched control stimulus presented to them on a computer monitor for a duration of five minutes. Visit 2: Participants will be instructed to smoke their cigarette using the CReSS device and instructions provided during Visit 1 after undergoing a brief laboratory stress induction.

Also known as: Attention Control

Control

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rutgers. The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Dr. Teresa Leyro
• Organization: Rutgers, the State University of New Jersey

tml124@psych.rutgers.edu

848-445-2090

Study Officials

• Teresa Leyro, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Samantha Farris, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: December 9, 2022
• Study Start: March 21, 2022
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: February 24, 2025
• Results First Posted: December 4, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication of primary study aims. Ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically and theoretically sound proposal that is not redundant with the primary aims or findings already reported

Locations

US (1)