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Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial

NCT05454657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-26

Study results available
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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.

Conditions

Interventions

DEVICE

Heart rate variability biofeedback + treatment as usual

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

BEHAVIORAL

Treatment as usual only

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

Sponsors & Collaborators

  • Colorado State University

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • David Eddie, Ph.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2024-09-15
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454657 on ClinicalTrials.gov