CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Heart rate variability biofeedback + treatment as usual +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05454657
NCT05454657N/ACompleted

A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder

Massachusetts General Hospital·interventional·Posted Jul 12, 2022·Updated Dec 26, 2025

In Brief

A clinical study evaluating Heart rate variability biofeedback + treatment as usual and Treatment as usual only for Substance Use Disorders. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Heart rate variability biofeedback (HRVB) is an biobehavioral intervention involving rhythmic breathing at resonance frequency that stimulates cardiovascular regulatory systems to help individuals better regulate affect and bolster cognitive control. This intervention has already shown its potential as a substance use disorder (SUD) treatment tool, but practical limitations of its accessibility, labor intensiveness, and cost have previously prevented this intervention from going to scale. Second-generation, ambulatory HRVB technology, however, has overcome these limitations and now allows patients to practice HRVB in-the-moment when its needed most. This study is testing the efficacy of second-generation, ambulatory HRVB for the first time with individuals with SUD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 12, 2022
Enrollment StartJan 4, 2023
Primary CompletionSep 15, 2024
Study CompletionJul 31, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.0 years ago

Interventions

Heart rate variability biofeedback + treatment as usualdevice

Heart rate variability biofeedback is a biobehavioral intervention involving rhythmic breathing at resonance frequency (RF) that stimulates the baroreflex and increases heart rate variability.

Treatment as usual onlybehavioral

Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.