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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 7, and week 16 (i.e., baseline, quit date, 2-wfu, 1-mfu, 3-mfu)
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 7, and week 16 (i.e., baseline, quit date, 2-wfu, 1-mfu, 3-mfu)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 3, week 5, week 7, and week 16 (i.e., baseline, quit date, 2-wfu, 1-mfu, 3-mfu) 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 Technological Limitations
Intervention Feasibility: Participant Attendance
+4 more
Secondary outcome measures
Changes in emotional distress
Changes in smoking behavior: Quit Day Abstinence
Changes in smoking behavior: Reduced Smoking Rate
+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
~7450

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,204 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,095 Total Patients Enrolled
Teresa M, Leyro, Ph.D.Principal InvestigatorRutgers, The State University of New Jersey

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are young adults within the target age range for this experiment?

"This trial's age requirements state that you must be between 21 and 50 years old to participate."

Answered by AI

Are volunteers still being sought for this research project?

"This clinical trial, the details of which are available on www.clinicaltrials.gov, is recruiting patients at this time. The listing for the study was created on 29 November 2021 and updated on 5 May 2022."

Answered by AI

Are there any risks associated withHeart Rate Variability Biofeedback (HRVB)?

"While there is limited data surrounding the efficacy of Heart Rate Variability Biofeedback (HRVB), Phase 2 trials suggest that it is a safe intervention. Our team at Power have given HRVB a score of 2."

Answered by AI

Who meets the requirements to join this clinical trial?

"This clinical trial is testing the effects of a new medication on tobacco users. To be eligible, candidates must be between 21 and 50 years old. The study will accept up to 60 participants in total."

Answered by AI

How many subjects are enrolled in this clinical trial?

"That is correct. The latest information on clinicaltrials.gov reveals that this study, which was first advertised on November 29th 2021, has an open enrollment for 60 patients at a single site."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Rutgers, School of Arts and Sciences, One Spring Street
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Rutgers, School of Arts and Sciences, One Spring Street: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
Current Opinion in PsychologyJournal
Theoretical Implications and Clinical Support for Heart Rate Variability Biofeedback for Substance Use Disorders
Leyro, Teresa M, Jennifer F Buckman, and Marsha E Bates. 2019. “Theoretical Implications and Clinical Support for Heart Rate Variability Biofeedback for Substance Use Disorders”. Current Opinion in Psychology. Elsevier BV. doi:10.1016/j.copsyc.2019.03.008.
clinicaltrials.govStudy
Heart Rate Variability Biofeedback for Smoking Cessation Treatment
Teresa M. Leyro, Ph.D. 2021. "Heart Rate Variability Biofeedback for Smoking Cessation Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05224050.
~8 spots leftby Apr 2025
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