N/A N=84 Randomized Double-blind Basic Science

Puff Biofeedback to Reduce Smoking Reinforcement

Cigarette Smoking

Bottom Line

View on ClinicalTrials.gov: NCT05644002 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Cigarette Purchase Task- Omax — 18.84; 18.80 cigarettes — p=.71

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Puff Topography Biofeedback Training (Behavioral); Control (Behavioral)
Age: Adult · 19+ yrs
Sex: All
Sponsor: Rutgers, The State University of New Jersey
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Cigarette Purchase Task- Omax	18.84; 18.80	.71
PRIMARY Modified Cigarette Evaluation Questionnaire - Cigarette Satisfaction Subscale	5.02; 5.27	.530
PRIMARY Cigarette Purchase Task - Intensity	13.86; 14.75	.66
PRIMARY Cigarette Purchase Task- Pmax	5.07; 4.37	.77
PRIMARY Cigarette Purchase Task- Breakpoint	8.85; 8.50	.90
PRIMARY Modified Cigarette Evaluation Questionnaire - Craving Reduction Subscale	5.692; 4.944	.09
PRIMARY Modified Cigarette Evaluation Questionnaire - Psychological Reward Subscale	4.144; 4.328	.666
SECONDARY Changes in Cardiac Vagal Control	4.916; 4.778	.73
SECONDARY Puff Topography	2.05; 1.51	.001 sig

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.

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).

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Data sourced from ClinicalTrials.gov (NCT05644002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.