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Heart Rate Variability Biofeedback for Smoking Cessation Treatment

NCT05224050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-05-01

Study results available
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Summary

The purpose of the study is to conduct an open trial examining the feasibility and acceptability of an adapted heart rate variability biofeedback and smoking cessation treatment that was using a primarily virtual remote intervention.

Conditions

  • Tobacco Smoking

Interventions

BEHAVIORAL

Cognitive-Behavioral Smoking Cessation

Participants will be 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.

BIOLOGICAL

Heart Rate Variability Biofeedback

Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.

DRUG

Nicotine patch

All participants will be 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 M, 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
2021-11-29
Primary Completion
2023-06-15
Completion
2023-06-15
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 NCT05224050 on ClinicalTrials.gov