Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Pro2019001539

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.

2021-11-29

2023-06-15

2023-06-15

Completed

Early phase I

28

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open trial with all participants receiving the experimental intervention (HRVB) in addition to smoking cessation therapy and nicotine replacement therapy patch.'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

2024-05-01