CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Transdermal Nicotine patch +2 moredrug
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/NCT03972137
NCT03972137Phase 2Completed
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Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation

Rutgers, The State University of New Jersey·interventional·Posted Jun 3, 2019·Updated Aug 25, 2020

In Brief

A Phase 2 clinical trial evaluating Cognitive-Behavioral Smoking Cessation, Heart Rate Variability Biofeedback (HRVB), and 1 other intervention for Tobacco Smoking. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Smoking
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 3, 2019
Enrollment StartApr 24, 2019
Primary CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.1 years ago

Interventions

Cognitive-Behavioral Smoking Cessationbehavioral

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.

Heart Rate Variability Biofeedback (HRVB)behavioral

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

Transdermal Nicotine patchdrug

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