Heart Rate Variability Biofeedback for Smoking Cessation (HRVB-SCT)

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 2

Conditions: Tobacco Smoking

Treatments: Behavioral: Cognitive-Behavioral Smoking Cessation; Behavioral: Heart Rate Variability Biofeedback (HRVB); Drug: Transdermal Nicotine patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03972137

R34DA043751 (U.S. NIH Grant/Contract)

2018001848

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Heart Rate Variability Biofeedback-Smoking Cessation Therapy

Experimental group

Description:

All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment (SCT), up to 8 weeks of the transdermal nicotine patch (NRT) and individualized heart rate variability biofeedback (HRVB).

Treatment:

Drug: Transdermal Nicotine patch

Behavioral: Heart Rate Variability Biofeedback (HRVB)

Behavioral: Cognitive-Behavioral Smoking Cessation