Phase 2 N=10 Treatment

Heart Rate Variability Biofeedback for Smoking Cessation

Tobacco Smoking

Bottom Line

View on ClinicalTrials.gov: NCT03972137 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Intervention Feasibility: Participant Attendance — 6.30; 8.71 Sessions

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cognitive-Behavioral Smoking Cessation (Behavioral); Heart Rate Variability Biofeedback (HRVB) (Behavioral); Transdermal Nicotine patch (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Rutgers, The State University of New Jersey
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Intervention Feasibility: Participant Attendance	6.30; 8.71	—
PRIMARY Intervention Feasibility: Participant Ratings of Effectiveness	3.03; 3.19	—
PRIMARY Intervention Feasibility: Participant Ratings of Appropriateness	3.61; 2.87	—
PRIMARY Intervention Feasibility: Participant Ratings of Ease of the Intervention	2.4; 1.58	—
PRIMARY Intervention Acceptability: Participant Ratings of Satisfaction and Liking	3.24; 3.52	—
SECONDARY Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)	6; 4; NA; 4; 2; 4	—
SECONDARY Cigarettes Smoked Per Day	11.56; 0.14; 0	.003 sig
SECONDARY Change in Total Emotional Distress	39.9; 23.5; 12.2; 13.75; 11.5; 5.0	.010 sig

Summary

Open trial of heart rate variability biofeedback as an adjunct to individualized smoking cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with elevated emotional distress.

Eligibility Criteria

Inclusion Criteria

Smoking ≥5 cigarettes, daily, for at least two years
expired carbon monoxide analysis of breath sample ≥8 ppm
elevated affective distress
motivation to quit
computer proficient

Exclusion Criteria

current use of other tobacco or nicotine products for recreation or to aid in cessation, use of pharmacological intervention for cessation, or current enrollment in a psychosocial intervention for smoking cessation
endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
inability to provide written informed consent
current evidence of another substance use disorder
severe visual or hearing impairments
self-reported medical condition or medication use that may be contraindicated for participation in a HRVB or confound autonomic parameters:
self-reported medical issues of potential concern to nicotine patch users

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03972137). 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.