Heart Rate Variability Biofeedback for Smoking Cessation

Completed · Phase 2

Conditions studied: Tobacco Smoking

In brief

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.

Key facts

Study ID

NCT03972137

Run by

Rutgers, The State University of New Jersey

People needed

10

Starts

2019-04-24

Expected to finish

2020-02-20

Last updated by the study team

2020-08-25

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Smoking ≥5 cigarettes, daily, for at least two years
• expired carbon monoxide analysis of breath sample ≥8 ppm
• elevated affective distress
• motivation to quit
• computer proficient

You may not qualify if…

• current use of other tobacco or nicotine products for recreation or to aid in cessation, use of pharmacological intervention for cessation, or current enrollment in a psychosocial intervention for smoking cessation
• endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
• inability to provide written informed consent
• current evidence of another substance use disorder
• severe visual or hearing impairments
• self-reported medical condition or medication use that may be contraindicated for participation in a HRVB or confound autonomic parameters:
• self-reported medical issues of potential concern to nicotine patch users

Where it is running

• Rutgers, School of Arts and Sciences, One Spring Street — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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