Clinical trial NCT05224050: Heart Rate Variability Biofeedback for Smoking Cessation Treatment
Official title: Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment
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: 2022-02-04
Enrollment: 28
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 will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to conduct an open trial examining the feasibility and acceptability of an adapted heart rate variability biofeedback and smoking cessation treatment that was using a primarily virtual remote intervention.

Detailed description: The present investigation is an open trial investigating the feasibility and acceptability of heart rate variability biofeedback smoking cessation treatment (HRVB-SCT) for individuals who smoke cigarettes. Significant findings will also support the expansion of HRVB as a transdiagnostic treatment adjunct that alters cardiac vagal functioning to promote emotional and behavioral regulation, changing the status quo of cognitive-behavioral intervention approaches and decreasing the health and economic burden of smokers who suffer from emotional distress.

The goals are to: (a) assess the feasibility and acceptability of the HRVB-SCT intervention (b) assess the efficacy of the intervention in modifying smoking behavior and emotional distress; and (c) collect additional information to inform a subsequent randomized clinical trial.

Eligibility criteria: Inclusion Criteria:

* Age 21-50
* Smoking ≥ 5 cigarettes, daily, for at least two years
* Expired carbon monoxide analysis of breath sample ≥8 ppm
* A score of \> 5 on the Readiness to Quit Ladder (i.e., desire to quit smoking within the next 6 months)
* Ability to read and speak English fluently
* Computer and Smartphone proficient

Exclusion Criteria:

* Use of other tobacco or nicotine products for recreation or to aid in cessation or use of medication to aid in smoking cessation or currently receiving counseling 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
* Self-reported pending legal issue with potential to result in incarceration
* Plan to move from the New Brunswick, New Jersey area within the next 6 months
* 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 heart rate variability biofeedback training or confound autonomic parameters: Being overweight or obese (i.e., body mass index \> 35); Severe asthma or breathing problems (e.g., chronic obstructive pulmonary disease, emphysema, bronchitis); currently pregnant or lactating or plans to become pregnant in the next 4 months; Autoimmune disorder (e.g., multiple sclerosis; under or overactive thyroid); Neurodegenerative disorder (e.g., Alzheimer's disease, Parkinson's disease); Current use of a psychotropic medication or use of other medication that may affect the cardiovascular system (e.g., mood stabilizers, anti-psychotics, monoamine oxidase inhibitors, tricyclics, beta blockers, benzodiazepines; patients taking selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors will be enrolled if on a stable regimen for at least 6 weeks); History of heart murmur or arrhythmia; Pacemaker or other implanted cardiac devices; Heart disease; or Abnormal heart or respiratory parameters including respiration rate \> 20 breaths per minute, extra systoles, or hypertension (e.g., blood pressure reading ≥ 140/90; this may be determined following baseline assessment. Importantly, the presence of any of these exclusion factors, if unknown to the participant would not put them at any risk if they participated in the study, it would simply make the cardiovascular data more difficult (if not impossible) to process and interpret, and
* Self-reported medical issues of potential concern to nicotine patch users (i.e., unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days

Primary outcomes:
measure: Intervention Feasibility: Participant Attendance
timeFrame: 6 weeks
measure: Intervention Feasibility: Participant Practice Adherence
timeFrame: 6 weeks
measure: Intervention Feasibility: Participant Ratings of Effectiveness
timeFrame: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)
measure: Intervention Feasibility: Participant Ratings of Appropriateness
timeFrame: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)
measure: Intervention Feasibility: Participant Ratings of Ease of the Intervention
timeFrame: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)
measure: Intervention Feasibility: Interventionist Ratings of Technical Issues
timeFrame: 6 weeks
measure: Intervention Acceptability: Participant Rating of Satisfaction and Liking
timeFrame: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)
Secondary outcomes:
measure: Changes in Total Emotional Distress
timeFrame: Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU)
measure: Changes in Smoking Behavior: Quit Day Abstinence
timeFrame: Week 3 (i.e., Quit Date)
measure: Changes in Smoking Behavior: Sustained Smoking Cessation
timeFrame: Week 16 (i.e., 3-MFU)
measure: Changes in Smoking Behavior: Reduced Smoking Rate
timeFrame: Week 0, Week 3, Week 5, Week 6, and Week 16 (i.e., Baseline, Quit Date, 2-Weeks Post-Quit, 1-Month Post-Quit, 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 M, 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.