Clinical trial NCT05644002: Puff Biofeedback to Reduce Smoking Reinforcement
Official title: A Puff Topography Biofeedback Paradigm to Reduce Stress-Precipitated Smoking Reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Smoking
Cigarette
Stress
Distress
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-12-09
Enrollment: 154
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Cigarette Purchase Task- Omax
timeFrame: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
measure: Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale
timeFrame: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
measure: Cigarette Purchase Task - Intensity
timeFrame: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
measure: Cigarette Purchase Task- Pmax
timeFrame: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
measure: Cigarette Purchase Task- Breakpoint
timeFrame: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 day.
measure: Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale
timeFrame: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
measure: Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale
timeFrame: Second Training Day following the Stress-Induction and Intervention (Smoking Task) i.e. post intervention, average 1 days.
Secondary outcomes:
measure: Changes in Cardiac Vagal Control
timeFrame: Second Training Day prior to Stress-Induction, and following Stress-Induction during Intervention (Smoking Task), average 1 day.
measure: Puff Topography
timeFrame: Second Training Day following Stress-Induction during Intervention (Smoking Task), average 1 day.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers. The State University of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Teresa Leyro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers, The State University of New Jersey
name: Samantha Farris, PhD
role: PRINCIPAL_INVESTIGATOR
References: