CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Heart Rate Variability Biofeedback +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05224050
NCT05224050Phase 2Completed

Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Rutgers, The State University of New Jersey·interventional·Posted Feb 4, 2022·Updated May 1, 2024

In Brief

A Phase 2 clinical trial evaluating Cognitive-Behavioral Smoking Cessation, Heart Rate Variability Biofeedback, and 1 other intervention for Tobacco Smoking. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Smoking
CountriesUnited States

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedFeb 4, 2022
Enrollment StartNov 29, 2021
Primary CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.4 years ago

Interventions

Cognitive-Behavioral Smoking Cessationbehavioral

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.

Heart Rate Variability Biofeedbackbiological

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

Nicotine patchdrug

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