Substance Use DisordersNCT05454657
Heart Rate Variability Biofeedback for Substance Use Disorder: A Randomized Clinical Trial
A study testing Heart rate variability biofeedback + treatment as usual and Treatment as usual only in people with Substance Use Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Heart rate variability biofeedback + treatment as usual and Treatment as usual only
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- Medical history of severe cardiac arrhythmia
- Active psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114-4714
About this study
Official title: A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder
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.
Read the detailed description
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.
- Conditions
- Substance Use Disorders
- Being tested
- Heart rate variability biofeedback + treatment as usual, Treatment as usual only
- Keywords
- Heart rate variability biofeedback, Just in time, Autonomic nervous system, Substance use disorder, Addiction recovery
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 onlyBehavioural
Treatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as usual only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Day-level Negative Affect
Average day-level score reported; Range = 0-10; higher values denote greater negative affect
Measured: 8 weeks
Day-level Positive Affect
Average day-level score reported; Range = 0-10; higher values denote greater positive affect
Measured: 8 weeks
Day-level Craving
Average day-level score reported; Range = 0-10; higher values denote greater craving
Measured: 8 weeks
Day-level Substance Use
Percent participants reporting any day-level substance use
Measured: 8 weeks
8-week Substance Use
Mean percent days abstinent over the 8-week intervention period
Measured: 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
Measured: 8 weeks
Secondary outcomes (3)
Change Craving
Change in craving measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
Measured: 8 weeks
Change Positive Affect
Change in positive affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
Measured: 8 weeks
Change Negative Affect
Change in negative affect measured by ecological momentary assessment over the 8-week intervention period, modeled using time-varying effects modeling (TVEM).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start4 Jan 2023
- Primary completion15 Sep 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Heart rate variability biofeedback + treatment as usual vs. treatment as usual only
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Principal investigator, David Eddie, Massachusetts General Hospital
- Investigators
- David Eddie, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454657
- Sponsor's protocol ID
- 2022P001496
- Status last verified
- Dec 2025
- First submitted
- 4 Jul 2022
- Last updated
- 26 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41032322
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05454657
- Acronym / sponsor ID
- 2022P001496
- Conditions
- Substance Use Disorders
- Keywords
- Heart rate variability biofeedback, Just in time, Autonomic nervous system, Substance use disorder, Addiction recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Posted 26 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Heart rate variability biofeedback + treatment as usual vs. treatment as usual only
| Arm | Type | Receives |
|---|---|---|
| Heart rate variability biofeedback + treatment as usual | Experimental | Device: Heart rate variability biofeedback + treatment as usual, Behavioral: Treatment as usual onlyThe 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. |
| Treatment as usual only | Active comparator | Behavioral: Treatment as usual onlyThe control group participated in 8 weeks of treatment as usual only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (2 listed)
- Medical history of severe cardiac arrhythmia
- Active psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedback + treatment as usualHeart rate variability biofeedback is a biobehavioral intervention involving rhythmic breathing at resonance frequency (RF) that stimulates the baroreflex and increases heart rate variability. | Device | Heart rate variability biofeedback + treatment as usual |
| Treatment as usual onlyTreatment as usual may include any outpatient substance use disorder treatment or mutual-help group participation. | Behavioural | Heart rate variability biofeedback + treatment as usual, Treatment as usual only |
Primary outcome
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
Day-level Negative Affect
Time frame: 8 weeks
Average day-level score reported; Range = 0-10; higher values denote greater negative affect
Day-level Positive Affect
Time frame: 8 weeks
Average day-level score reported; Range = 0-10; higher values denote greater positive affect
Day-level Craving
Time frame: 8 weeks
Average day-level score reported; Range = 0-10; higher values denote greater craving
Day-level Substance Use
Time frame: 8 weeks
Percent participants reporting any day-level substance use
8-week Substance Use
Time frame: 8 weeks
Mean percent days abstinent over the 8-week intervention period
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
3 secondary outcomes
Change Craving
Time frame: 8 weeks
Change Positive Affect
Time frame: 8 weeks
Change Negative Affect
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41032322Eddie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Eddie, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback + treatment as usual and Treatment as usual only in people with Substance Use Disorders, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability Biofeedback Engagement (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.