Heart Rate Variability Biofeedback for Smoking Cessation
NCT ID: NCT03972137
Last Updated: 2020-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2019-04-24
2020-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Heart Rate Variability Biofeedback-Smoking Cessation Therapy
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).
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.
Heart Rate Variability Biofeedback (HRVB)
All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
Transdermal Nicotine patch
All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Interventions
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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.
Heart Rate Variability Biofeedback (HRVB)
All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
Transdermal Nicotine patch
All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* expired carbon monoxide analysis of breath sample ≥8 ppm
* elevated affective distress
* motivation to quit
* computer proficient
Exclusion Criteria
* 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
21 Years
50 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Teresa M. Leyro, Ph.D.
Associate Professor
Principal Investigators
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Teresa Leyro, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Rutgers, The State University of New Jersey
Locations
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Rutgers, School of Arts and Sciences, One Spring Street
New Brunswick, New Jersey, United States
Countries
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References
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Leyro TM, Buckman JF, Bates ME. Theoretical implications and clinical support for heart rate variability biofeedback for substance use disorders. Curr Opin Psychol. 2019 Dec;30:92-97. doi: 10.1016/j.copsyc.2019.03.008. Epub 2019 Apr 2.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018001848
Identifier Type: -
Identifier Source: org_study_id
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