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Heart Rate Variability Biofeedback for Smoking Cessation

NCT03972137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-08-25

Study results available
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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.

Conditions

  • Tobacco Smoking

Interventions

BEHAVIORAL

Cognitive-Behavioral Smoking Cessation

Participants were provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.

BEHAVIORAL

Heart Rate Variability Biofeedback (HRVB)

All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.

DRUG

Transdermal Nicotine patch

All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Teresa Leyro, Ph.D. · Rutgers, The State University of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2020-02-20
Completion
2020-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972137 on ClinicalTrials.gov