N/A
N=120
Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial
Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT05454657 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Heart Rate Variability Biofeedback Engagement — 15; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heart rate variability biofeedback + treatment as usual (Device); Treatment as usual only (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate Variability Biofeedback Engagement |
15; 0 | — |
| PRIMARY Day-level Negative Affect |
2.96; 3.36 | <.05 sig |
| PRIMARY Day-level Positive Affect |
5.26; 5.02 | <.05 sig |
| PRIMARY Day-level Craving |
2.32; 2.25 | <.05 sig |
| PRIMARY Day-level Substance Use |
6; 5 | <0.05 sig |
| PRIMARY 8-week Substance Use |
91.79; 90.33 | .660 |
| PRIMARY Odds Ratio of Within-day Association Between AOD Craving and AOD Use |
0.84; 1.00 | — |
| SECONDARY Change Craving |
— | — |
| SECONDARY Change Positive Affect |
— | — |
| SECONDARY Change Negative Affect |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Own a smartphone
- English proficiency
- DSM 5 diagnosis of substance use disorder
- In the first year of a current substance use disorder recovery attempt with a goal of total alcohol and other drug abstinence
Exclusion Criteria
- Medical history of severe cardiac arrhythmia
- Active psychosis
Data sourced from ClinicalTrials.gov (NCT05454657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.