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

NCT05454657 | Completed Results FDA Device

• 1 other identifier: 2022P001496
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Substance Use Disorders

Keywords

Heart rate variability biofeedback; Just in time; Autonomic nervous system; Substance use disorder; Addiction recovery

Outcome Measures

Primary Outcomes (7)

• Heart Rate Variability Biofeedback Engagement

  Number of participants with ≥50% daily-practice adherence to the study practice target of 15 minutes per day, inclusive of scheduled and self-initiated HRVB practice

  8 weeks

• Day-level Negative Affect

  Average day-level score reported; Range = 0-10; higher values denote greater negative affect

  8 weeks

• Day-level Positive Affect

  Average day-level score reported; Range = 0-10; higher values denote greater positive affect

  8 weeks

• Day-level Craving

  Average day-level score reported; Range = 0-10; higher values denote greater craving

  8 weeks

• Day-level Substance Use

  Percent participants reporting any day-level substance use

  8 weeks

• 8-week Substance Use

  Mean percent days abstinent over the 8-week intervention period

  8 weeks

• Odds Ratio of Within-day Association Between AOD Craving and AOD Use

  Within-day association between alcohol and other drug (AOD) craving earlier in the day and the odds of AOD use later that same day

  8 weeks

Secondary Outcomes (3)

• Change Craving

  8 weeks

• Change Positive Affect

  8 weeks

• Change Negative Affect

  8 weeks

Study Arms (2)

Heart rate variability biofeedback + treatment as usual

EXPERIMENTAL

The experimental group participated in 8 weeks of Heart Rate Variability Biofeedback (HRVB) practice using the Lief HRVB Smart Patch and smartphone app + treatment as usual. Participants were asked to, 1) wear the Lief Smart Patch for at least 8 hours per day, 2) do 10mins of scheduled HRVB practice daily, and 3) do at least 5mins per day of HRVB practice in-the-moment when negative affect/craving arose, or in response to just-in-time prompts to do brief bursts of HRVB when the device sensed autonomic arousal indicative of stress.

Device: Heart rate variability biofeedback + treatment as usual; Behavioral: Treatment as usual only

Treatment as usual only

ACTIVE COMPARATOR

The control group participated in 8 weeks of treatment as usual only.

Behavioral: Treatment as usual only

Interventions

Heart rate variability biofeedback + treatment as usual DEVICE

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

Heart rate variability biofeedback + treatment as usual

Treatment as usual only BEHAVIORAL

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

Heart rate variability biofeedback + treatment as usual; Treatment as usual only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• Medical history of severe cardiac arrhythmia
• Active psychosis

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Colorado State University: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114-4714, United States

Location

Related Publications (1)

• Eddie D, Nguyen M, Zeng K, Mei S, Emery N. Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1177-1185. doi: 10.1001/jamapsychiatry.2025.2700.

  PMID: 41032322 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Limitations include: (1) a modest sample size and no placebo group, reflecting the phase II stage of the trial; (2) focus on individuals in their first year of abstinence-based SUD recovery, enhancing relevance for this group but limiting generalizability; (3) lack of follow-up; and (4) testing only the hypothesized moderation effect of HRVB on the craving-AOD use relationship, without examining other mechanisms.

Results Point of Contact

• Title: Dr. David Eddie
• Organization: Massachusetts General Hospital / Harvard Medical School

deddie@mgh.harvard.edu

6176439194

Study Officials

• David Eddie, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Heart rate variability biofeedback + treatment as usual vs. treatment as usual only

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 12, 2022
• Study Start: January 4, 2023
• Primary Completion: September 15, 2024
• Study Completion: July 31, 2025
• Last Updated: December 26, 2025
• Results First Posted: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)