Heart Rate Variability Biofeedback for Smoking Cessation Treatment

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

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.

It had 1 arm (groups): Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT) (experimental).

The registry classes the interventions as behavioral, biological and drug.

More on the Plan

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.

Who Took Part

28 actual participants took part.

It was open to people of any sex aged from 21 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: 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; inability to provide written informed consent.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-11-29 with completion listed for 2023-06-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Intervention Feasibility: Participant Attendance (time frame: 6 weeks). Intervention Feasibility: Participant Practice Adherence (time frame: 6 weeks). Intervention Feasibility: Participant Ratings of Appropriateness (time frame: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)).

It also tracked 4 secondary outcomes, for example Changes in Total Emotional Distress, Changes in Smoking Behavior: Quit Day Abstinence and Changes in Smoking Behavior: Sustained Smoking Cessation.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Therapeutic nicotine (patch, non-peptide) in 28 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.