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Completed

NCT Number: NCT05454657

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114-4714, United States

About this study

Alcohol and other drug use (AOD) lapses in early substance use disorder (SUD) recovery typically arise from interactions between aversive affective states and stressors that together elicit urges to use. A central goal of first-line cognitive-behavioral SUD treatments is to strengthen affective and cognitive control to increase individuals' ability to override impulses to use AOD. Yet certain automatic physiological processes compromised by SUD dynamically interact with internal affective states and environmental cues to undermine effortful cognitive control and outcompete cognitive goals to avoid substance use.

Heart rate variability biofeedback (HRVB) is a biobehavioral intervention involving rhythmic breathing at resonance frequency (RF) that stimulates the body's baroreflex mechanism to offset these psychophysiological deficits. The autonomic normalization effected by RF breathing is thought to bolster cognitive control efforts by interrupting or dampening automatic-visceral reactions that can undermine treatment gains, and in doing so support better decision-making, motivation, reductions in craving, and shifts in attention allocation.

Previous studies of HRVB have focused on positive behavioral effects that accrue over a series of weeks or months, rather than 'in-the-moment'. These chronic behavior changes, although clinically valuable, are labor and time intensive to elicit, reducing the likelihood of large-scale uptake of the intervention. Further, first-generation HRVB's regular daily practice model is likely to only partially mitigate the intense momentary bouts of emotion dysregulation that are triggers for AOD use in those in early SUD recovery. In contrast, recent studies have demonstrated that a brief exposure to RF breathing in anticipation of psychosocial stress, or during induced stress, helps to control physiological arousal, reduce state anxiety, and improve cognitive performance. It is posited that such bursts of in-the-moment HRVB practice could serve as a potent SUD treatment tool that helps individuals self-regulate emotions when needed most.

Recent advances in the field have given rise to small, lightweight, wearable biosensors that can allow wearers to do HRVB on-the-go. These devices also have the capacity to function as a just-in-time intervention by prompting in-the-moment HRVB practice when autonomic hyperarousal is detected, to buffer salient triggers and urges to use AOD. This research builds on a body of preliminary work speaking to HRVB's potential as an addendum to first-line SUD treatments by exploring for the first time in this disorder this second-generation, ambulatory, HRVB technology. Specific aims of this research include, 1) assessing ambulatory HRVB's uptake by individuals with SUD, 2) testing day-level effects of in-the-moment HRVB practice on affective states and substance use, and 3) testing the accumulative effects of scheduled daily HRVB practice, in-the-moment HRVB practice, and their combination, on substance use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Treatment As Usual Only

Behavioral

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

Primary outcomes

  1. Heart Rate Variability Biofeedback Engagement

    Time frame: 8 weeks

    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

  2. Day-level Negative Affect

    Time frame: 8 weeks

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

  3. Day-level Positive Affect

    Time frame: 8 weeks

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

  4. Day-level Craving

    Time frame: 8 weeks

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

  5. Day-level Substance Use

    Time frame: 8 weeks

    Percent participants reporting any day-level substance use

  6. 8-week Substance Use

    Time frame: 8 weeks

    Mean percent days abstinent over the 8-week intervention period

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

    Time frame: 8 weeks

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

Secondary outcomes

  1. Change Craving

    Time frame: 8 weeks

    Change in craving measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).

  2. Change Positive Affect

    Time frame: 8 weeks

    Change in positive affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).

  3. Change Negative Affect

    Time frame: 8 weeks

    Change in negative affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Colorado State University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 12, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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