NCT03972137

Heart Rate Variability Biofeedback for Smoking Cessation

Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The investigators propose to develop and pilot test heart rate variability biofeedback (HRVB) for smokers with elevated emotional distress as an adjunct to individual smoking cessation counseling (SCT) and transdermal nicotine patch (NRT). In this open trial, all participants received the active intervention. Findings will be used to refine the protocol in advance of a subsequent Phase III randomized clinical trial.

Conditions

• Tobacco Smoking

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-24
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2019-06-03
• Last updated: 2020-08-25
• Results posted: 2020-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study