← Back to Search

Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT) for Tobacco Smoking (HRVB-SCT Trial)

Phase 2
Waitlist Available
Led By Teresa M, Leyro, Ph.D.
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 3, week 5, week 6, and week 16 (i.e., baseline, quit date, 2-weeks post-quit, 1-month post-quit, 3-month follow up)
Awards & highlights

HRVB-SCT Trial Summary

This trial will test whether heart rate variability biofeedback or breath awareness training can help smokers with moderate emotional distress quit smoking.

HRVB-SCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 3, week 5, week 6, and week 16 (i.e., baseline, quit date, 2-weeks post-quit, 1-month post-quit, 3-month follow up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 3, week 5, week 6, and week 16 (i.e., baseline, quit date, 2-weeks post-quit, 1-month post-quit, 3-month follow up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intervention Acceptability: Participant Rating of Satisfaction and Liking
Intervention Feasibility: Interventionist Ratings of Technical Issues
Intervention Feasibility: Participant Attendance
+4 more
Secondary outcome measures
Changes in Smoking Behavior: Quit Day Abstinence
Changes in Smoking Behavior: Reduced Smoking Rate
Changes in Smoking Behavior: Sustained Smoking Cessation
+1 more
Other outcome measures
Distress Tolerance as indexed by the Distress Tolerance Scale (DTS)
Vagal Functioning as indexed by High Frequency Heart Rate Variability Data

HRVB-SCT Trial Design

1Treatment groups
Experimental Treatment
Group I: Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)Experimental Treatment3 Interventions
All participants in this open trial will receive individualized training in resonance breathing using biofeedback to help improve self-regulation (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive-Behavioral Smoking Cessation
2021
Completed Phase 2
~40
Heart Rate Variability Biofeedback
2021
Completed Phase 2
~120
Nicotine patch
2015
Completed Phase 4
~6130

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
431 Previous Clinical Trials
64,630 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,492 Previous Clinical Trials
2,623,028 Total Patients Enrolled
Teresa M, Leyro, Ph.D.Principal InvestigatorRutgers, The State University of New Jersey
~8 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top