Clinical trial NCT03972137: Heart Rate Variability Biofeedback for Smoking Cessation
Official title: Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Smoking
Keywords: Smoking Cessation
Heart rate variability biofeedback
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Feasibility: Participant Attendance
timeFrame: 7 weeks
measure: Intervention Feasibility: Participant Ratings of Effectiveness
timeFrame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
measure: Intervention Feasibility: Participant Ratings of Appropriateness
timeFrame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
measure: Intervention Feasibility: Participant Ratings of Ease of the Intervention
timeFrame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
measure: Intervention Acceptability: Participant Ratings of Satisfaction and Liking
timeFrame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Secondary outcomes:
measure: Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)
timeFrame: Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
measure: Cigarettes Smoked Per Day
timeFrame: Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
measure: Change in Total Emotional Distress
timeFrame: Week 0 (i.e., baseline), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit) and Week 16 (i.e., 3-month follow-up)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, School of Arts and Sciences, One Spring Street
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Teresa Leyro, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.