Heart Rate Variability Biofeedback for Smoking Cessation

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

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.

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

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).

The registry classes the interventions as behavioral and drug.

More on the Plan

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.

Who Took Part

10 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. Elevated affective distress. Motivation to quit.

The full record lists 5 inclusion and 7 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; inability to provide written informed consent; current evidence of another substance use disorder.

How the Study Was Run

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

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2019-04-24 with completion listed for 2020-02-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Intervention Feasibility: Participant Attendance (time frame: 7 weeks). Intervention Feasibility: Participant Ratings of Appropriateness (time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)). Intervention Feasibility: Participant Ratings of Ease of the Intervention (time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)).

It also tracked 3 secondary outcomes, for example Cigarettes Smoked Per Day and Change in Total Emotional Distress.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Therapeutic nicotine (patch, non-peptide) in 10 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.