Puff Biofeedback to Reduce Smoking Reinforcement

Rutgers The State University of New Jersey

Status: Completed

Conditions: Cigarette Smoking

Treatments: Behavioral: Control; Behavioral: Puff Topography Biofeedback Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05644002

R21DA052723 (U.S. NIH Grant/Contract)

Pro2020000645

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

Control

Sham Comparator group

Description:

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

Treatment:

Behavioral: Control

Puff Topography Biofeedback Training (PTBT)

Experimental group

Description:

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

Treatment:

Behavioral: Puff Topography Biofeedback Training